Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event
Item
Did the Subject experience any Serious adverse events?
boolean
C1519255 (UMLS CUI [1])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/ Not resolving (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Single episode (1)
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not Applicable (6)
Item
Did the subject withdraw from the study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Did the subject withdraw from the study as a result of this AE?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product