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Non-Serious Adverse Events

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Description

Assessment Date

Type de données

text

Alias
UMLS CUI [1]
C2985720
Subject Number
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Description

Non-serious Adverse Event

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

(Please report all serious adverse events only on the Serious Adverse Event (SAE) report). If yes, please complte the following table.

Type de données

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event Record
Description

Non-Serious Adverse Event Record

Alias
UMLS CUI-1
C1518404
Description
Description

Description

Type de données

text

Alias
UMLS CUI [1]
C0678257
Administration Site
Description

Administration Site

Type de données

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1]
C0808070
during immediate postvaccination period (30 minutes)
Description

NSAE Started Immediately

Type de données

boolean

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0205253
Date Stopped
Description

End date

Type de données

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Description

Maximum Intensity

Type de données

text

Alias
UMLS CUI [1]
C1710066
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Products

Type de données

text

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

Outcome

Type de données

integer

Alias
UMLS CUI [1]
C1705586
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Similar models

Non-Serious Adverse Events

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Assessment Date
text
C2985720 (UMLS CUI [1])
Assessment Date
Code List
Assessment Date
CL Item
Visit 1 (Visit 1)
CL Item
Visit 2 (Visit 2)
CL Item
Telephone Contact (Telephone Contact)
CL Item
Visit 3 (Visit 3)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious adverse Event
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])
Item Group
Non-Serious Adverse Event Record
C1518404 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Code List
Administration Site
CL Item
Administration Site (L)
CL Item
Non-administration Site (G)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
NSAE Started Immediately
Item
during immediate postvaccination period (30 minutes)
boolean
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
End date
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Products
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
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