Non-Serious Adverse event occurred
Item
Has any non-serious adverse event (leading to drop-outs) occurred since Visit 1 until Visit 5?
boolean
C1518404 (UMLS CUI [1])
Item
Non-serious Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event Number
Non-serious Adverse Event Description
Item
Non-serious Adverse Event Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date Non-serious Adverse Event Started
Item
Date Non-serious Adverse Event Started
date
C1518404 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Adverse Event Started During Immediate Postvaccination Period
Item
Adverse Event Started During Immediate Postvaccination Period
boolean
C0231291 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date Adverse Event Stopped
Item
Date Adverse Event Stopped
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
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])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (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)