Sequence Number
Item
1. Sequence Number
integer
C2348184 (UMLS CUI [1])
Event
Item
2. Event
text
C0877248 (UMLS CUI [1])
Modified term
Item
3. Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C0871468 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Adverse Event Start Date Time
Item
4. Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Outcome End Date and Time
Item
5. Outcome / End Date and Time
datetime
C1705586 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
6. Frequency
text
C1561548 (UMLS CUI [1])
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
Item
7.Maximum Intensity
text
C1710056 (UMLS CUI [1])
Code List
7.Maximum Intensity
CL Item
Moderate (Moderate)
CL Item
Not applicable (Not applicable)
Item
8. Maximum Toxicity
text
C1710066 (UMLS CUI [1])
Code List
8. Maximum Toxicity
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
9. Maximum Toxicity or Intensity
text
C1710066 (UMLS CUI [1])
Code List
9. Maximum Toxicity or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
10. Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Code List
10. Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Withdrawal by Subject
Item
11. Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1])
adverse event study drug
Item
12. Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
duration adverse event
Item
13. Duration of AE if < 24 hours
text
C0449238 (UMLS CUI [1,1])
Time to Onset Since Last Dose
Item
14. Time to Onset Since Last Dose
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])