Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Event
Item
Event
text
C1518404 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date
Item
Non- Serious Adverse Event Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
Non- Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non- Serious Adverse Event Outcome
text
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)
Item
Non- Serious Adverse Event Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non- Serious Adverse Event Frequency
CL Item
Single Episode (1)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
[X] Not applicable (4)
Item
Intensity at onset of event
text
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Code List
Intensity at onset of event
CL Item
[X] Not applicable (4)
Item
Maximum Grade
text
C0441800 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Item
Grade at onset of event
text
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Code List
Grade at onset of event
Item
Maximum Grade or Intensity
text
C0441800 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Code List
Maximum Grade or Intensity
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[X] Not applicable (6)
Item
Grade or Intensity at onset of event
text
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
Code List
Grade or Intensity at onset of event
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[X] Not applicable (6)
Item
Action Taken with Investigational Product(s) as a result of the AE
text
C1704758 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Code List
Action Taken with Investigational Product(s) as a result of the AE
CL Item
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
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
C1710677 (UMLS CUI [1,1])
C1518404 (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
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])