person reporting sae
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
serious adverse event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
serious adverse event onset
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
serious adverse event end
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
Item
Event Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
serious adverse event episodes
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity (maximum)
CL Item
Moderate (Moderate)
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C3828190 (UMLS CUI [1])
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
results in disability/ incapacity (D)
CL Item
congenital anomaly/ birth defect (E)
CL Item
other (see definition) (F)
serious adverse event reason
Item
Please specify other:
text
C3828190 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
study medication reintroduced
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
SAE recur
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Relationship to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (reasonable possibility) (Suspected (reasonable possibility))
CL Item
Probable (Probable)
Item
The SAE is probably associated with:
text
C1706737 (UMLS CUI [1])
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (Protocol design or procedures (but not to study drug))
CL Item
Another condition (e.g. condition under study, intercurrent illness) (Another condition (e.g. condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
SAE association
Item
Please specify:
text
C1706737 (UMLS CUI [1])
corrective therapy
Item
Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn due to adverse event
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
SAE remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
randomisation number
Item
Randomisation/ Study Medication Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
laboratory test
Item
Test
text
C0022885 (UMLS CUI [1])
laboratory date
Item
Date
date
C0022877 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory value
Item
Value
text
C0022877 (UMLS CUI [1])
unit
Item
Units
text
C1519795 (UMLS CUI [1])
normal range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
cause of death
Item
Certified Cause of Death
text
C0007465 (UMLS CUI [1])
date of death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
autopsy
Item
Was an autopsy done?
boolean
C0004398 (UMLS CUI [1])
autopsy
Item
If YES, please summarize findings (include diagnosis):
text
C0004398 (UMLS CUI [1])
date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1])
comment
Item
Comment
text
C0947611 (UMLS CUI [1])
adverse event forms completed
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
concomitant medication form up to date
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
signing
Item
Check that all appropriate pages are signed (thus indicating completition) an dated
boolean
C1519316 (UMLS CUI [1])
laboratory results included
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])