Non-Serious Adverse Events

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

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

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
Description

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Description

Non-serious Adverse Event, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Description

Non-serious Adverse Event, Description

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Please check box in case of new onset of chronic diseases
Description

Non-serious Adverse Event, Chronic disease, New Onset

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0449244
Date Started
Description

Non-serious Adverse Event, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
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, Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
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, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit
Description

Non-serious Adverse Event, Visit, Advice, Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
Description

Non-serious Adverse Event, Visit, Advice, Medical, Type

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307

Similar models

Non-Serious Adverse Events

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Has any of the following non-serious adverse events been occurred during the study period? - New onset of chronic diseases - Conditions prompting emergency room visits not related to common diseases - Conditions prompting physician visits not related to common diseases
boolean
C1518404 (UMLS CUI [1])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, Chronic disease, New Onset
Item
Please check box in case of new onset of chronic diseases
boolean
C1518404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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])
C1710066 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-serious Adverse Event, Relationship, Experimental drug
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])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
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)
Non-serious Adverse Event, Visit, Advice, Medical
Item
Medically attended visit
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-serious Adverse Event, Visit, Advice, Medical, Type
Item
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
text
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])