Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
reason death
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- Results in death
boolean
C0392360 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
reason life threatening
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- life threatening
boolean
C0392360 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
reason hospitalization
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- results in hospitalisation or prolongation of existing hospitalisation
boolean
C0392360 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
reason disability
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- results in disability/incapacity
boolean
C0392360 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
reason congenital abnormality
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- congenital abnormality/birth defect
boolean
C0392360 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
reason other
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- other (Please specify)
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Number of episodes
Item
No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
dosage change
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0420247 (UMLS CUI [1])
Serious Adverse Experiences recurrence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
Item
The SAE is probably associated with:
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (Protocol design or procedures)
CL Item
Another condition (eg, condition under study, intercurrent illness) (Another condition (eg, condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
specify
Item
Please specify
text
C1521902 (UMLS CUI [1])
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date
Item
Date
text
C0011008 (UMLS CUI [1])
Value
Item
Value
text
C1522609 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation/Study medication number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigators Signature
Item
Investigator’s Signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
name
Item
Please PRINT Name
text
C0027365 (UMLS CUI [1])
Medical Monitor’s Signature
Item
SB Medical Monitor’s Signature:
text
C2346576 (UMLS CUI [1])
Name
Item
Please PRINT Name
text
C0027365 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])