TABLE 3.

Adverse events recorded in both the control and TRV027 group categorized by seriousness, graded for severity and causal relationship to study drug

	Control		TRV027
	No. of events	No. of subjects	No. of events	No. of subjects
Number of serious adverse events	3	3	5	4
Reasons for SAE
Resulted in death	1	1	2	2
Life threatening	2	2	1	1
Congenital anomaly/birth defect	0	0	0	0
Persistent or significant	0	0	0	0
Disability/incapacity	0	0	0	0
Prolongation of hospitalization	0	0	2	2
Other	0	0	0	0
Severity
Mild	0	0	0	0
Moderate	0	0	0	0
Severe	1	1	3	2
Life threatening	1	1	0	0
Death	1	1	2	2
Causal relationship to study drug
Definitely	0	0	0	0
Probably	0	0	0	0
Possibly	0	0	0	0
Unlikely	0	0	0	0
Not related	3	3	5	4
Not assessable	0	0	0	0