Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (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])
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])
Code List
Maximum Intensity
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])