Englisch

Non-Serious Adverse Events

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

For WB 1+3: Core Anaylsis 1 after 6 Month + 30 days and Core Analysis 2 after 12 Month For WB 2+4: Core Analysis 1 after 6 Month and Core Analysis 2 after 12 Month + 30 days

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Collection Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1317250
Has any non-serious adverse events occurred during study, excluding those recorded on the Solicited Adverse Events pages? (According to the reporting period determined in the protocol).
Beschreibung

If you tick yes, please complete following items.

Datentyp

text

Alias
UMLS CUI [1]
C1518404
AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description of AE
Beschreibung

Description of AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Site of AE
Beschreibung

Site of AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
Start Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2697888
AE start immediate during post-vaccination period (30 minutes)
Beschreibung

Tick if AE occurs immediate during post-vaccination period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205253
Stop Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
Maximum Intensity of AE
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome of AE
Beschreibung

Outcome of AE

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beschreibung

Type of medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Comment
Beschreibung

For GSK

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Non-Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Core analysis 1 (1)
CL Item
Core analysis 2 (2)
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Collection Date
Item
Collection Date
date
C1317250 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred during study, excluding those recorded on the Solicited Adverse Events pages? (According to the reporting period determined in the protocol).
text
C1518404 (UMLS CUI [1])
Non-serious adverse event
Code List
Has any non-serious adverse events occurred during study, excluding those recorded on the Solicited Adverse Events pages? (According to the reporting period determined in the protocol).
CL Item
Yes (Y)
CL Item
No (N)
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description of AE
Item
Description of AE
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Site of AE
text
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Site of AE
Code List
Site of AE
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Start Date of AE
Item
Start Date of AE
date
C2697888 (UMLS CUI [1])
AE start during post-vaccination period
Item
AE start immediate during post-vaccination period (30 minutes)
boolean
C0877248 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
Stop Date of AE
Item
Stop Date of AE
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Maximum Intensity of AE
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity of AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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
Yes (Y)
CL Item
No (N)
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
Yes (Y)
CL Item
No (N)
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Type of medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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