Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Non-serious Adverse Event - Start Date
Item
Non-serious Adverse Event - Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event - Start Time
Item
Non-serious Adverse Event - Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-serious Adverse Event - Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event - Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Non-serious Adverse Event - End Date
Item
Non-serious Adverse Event - End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event - End Time
Item
Non-Serious Adverse Event - End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-serious Adverse Event - Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event - Frequency
CL Item
Signle episode (1)
Item
Non-serious Adverse Event - Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Non-serious Adverse Event - Maximum Intensity
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
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])