adverse event, sequence number
Item
sequence number
text
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
adverse event, diagnosis or sign/symptom
Item
event, diagnosis only (if known) otherwise sign/symptom
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
adverse event; modified reported term
Item
modified term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
failed coding
Item
failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
adverse event start date and time
Item
start date and time
datetime
C2826806 (UMLS CUI [1])
Item
outcome
text
C1705586 (UMLS CUI [1])
CL Item
recovert/resolved (1)
CL Item
recovering/resolving (2)
CL Item
not recovert/notresolved (3)
CL Item
recovered/resolved with sequelae (4)
recovered or resolved, adverse event end date and time
Item
recovered/resolved, provide end date and time
datetime
C2826793 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
recovered/resolved with sequelae, adverse event end date and time
Item
recovered/resolved with sequelae, provide end date and time.
datetime
C2826793 (UMLS CUI [1,1])
C1709862 (UMLS CUI [1,2])
adverse event fatal, date and time of death
Item
fatal, record Date and Time of Death
datetime
C2826793 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C2826793 (UMLS CUI [2,1])
C1301931 (UMLS CUI [2,2])
Item
frequency
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
CL Item
single episode (1)
Item
maximum intensity
text
C1710066 (UMLS CUI [1])
Code List
maximum intensity
CL Item
not applicable (4)
Item
action taken with investigational product(s) as a result of the AE
text
C1704758 (UMLS CUI [1])
Code List
action taken with investigational product(s) as a result of the AE
CL Item
investigational product(s) withdrawn (1)
CL Item
dose increased (3)
CL Item
dose not changed (4)
CL Item
dose interrupted (5)
CL Item
not applicable (6)
subject withdawal
Item
did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
possibility that AE was caused by investigational product
Item
is there a reasonable possibility that the AE may have been caused by the investigational product
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
serious adverse event
Item
does this adverse event meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
serious adverse event, results in death
Item
serious adverse event resulting in death
boolean
C1705232 (UMLS CUI [1])
serious adverse event, life threatening
Item
serious adverse event, life threatening
boolean
C1517874 (UMLS CUI [1])
serious adverse event, requiring hospitalisation or prolongation of existing hospitalisation
Item
serious adverse event, requiring hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
serious adverse event, resulting in disability/incapacity
Item
serious adverse event, resulting in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C3176592 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0231170 (UMLS CUI [2,2])
serious adverse event, causing congenital anomaly/birth defect
Item
serious adverse event, causing congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
serious adverse event, other
Item
serious adverse event, other
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
serious adverse event, other specification
Item
if other, please specify:
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
serious adverse event, caused by activity related to study participation
Item
if it was a serious adverse event, was this caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
serious flag
Item
serious flag
text
C0205404 (UMLS CUI [1,1])
C1708067 (UMLS CUI [1,2])