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Non-Serious Adverse Events

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

If yes, please complete the following item group for each non-serious adverse event.

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C1517001
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
AE Number
Description

Non-serious adverse events number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0600091
Description
Description

Non-serious adverse event description

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Location
Description

Non-serious adverse event anatomic site

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1515974
For GSK
Description

Clinical study sponsor comment

Data type

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
Date started
Description

Non-serious adverse event start date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
During immediate post-vaccination period (60 minutes)?
Description

Non-serious adverse event start date immediately post vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date stopped
Description

Non-serious adverse event end date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum intensity
Description

Non-serious adverse event maximum symptom intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-serious adverse event relationship to investigational products

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome
Description

Non-serious adverse event outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
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Similar models

Non-Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious adverse event post vaccination | excluding solicited adverse events
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious adverse events number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Non-serious adverse event description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Location
text
C1518404 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Non-serious adverse event location
Code List
Location
CL Item
Administration sites ([L])
(Comment:en)
CL Item
Non-administration site ([G])
(Comment:en)
Clinical study sponsor comment
Item
For GSK
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Non-serious adverse event start date
Item
Date started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious adverse event start date immediately post vaccination
Item
During immediate post-vaccination period (60 minutes)?
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Non-serious adverse event end date
Item
Date stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious adverse event maximum symptom intensity
Code List
Maximum intensity
CL Item
Mild ([1])
CL Item
Moderate ([2])
CL Item
Severe ([3])
Non-serious adverse event relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious adverse event outcome
Code List
Outcome
CL Item
Recovered / resolved ([1])
(Comment:en)
CL Item
Recovering / resolving ([2])
(Comment:en)
CL Item
Not recovered / not resolved ([3])
(Comment:en)
CL Item
Recovered with sequelae / resolved with sequelae ([4])
(Comment:en)
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