Adverse Event, Numbers
Item
Sequence Number
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Event
Item
Event - Diagnosis Only (if known), Otherwise Signs/Symptoms
text
C0877248 (UMLS CUI [1])
Adverse Event
Item
Modified term
text
C0877248 (UMLS CUI [1])
Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Adverse Event, End Date, End time
Item
End Date and Time
datetime
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Adverse Event, Date of Death, Time of Death
Item
Date and Time of Death
datetime
C0877248 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C1301931 (UMLS CUI [1,3])
Item
Frequency
text
C0877248 (UMLS CUI [1,1])
C0439603 (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
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
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Investigational product(s) withdrawn (1)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)
Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0877248 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Adverse Event, Relationship, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event
Item
Does this Adverse Event meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
Item
If Yes, check all that apply
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
If Yes, check all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify (6)
Serious Adverse Event, Reason and justification
Item
Other, specify
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Item
Was this SAE caused by an activity related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])