TABLE 3.

Summary of adverse events (safety population)^a,b

Participants with ≥1 event	WCK 6777 2 g (N = 6)	ERT 2 g (N = 6)	ZID 2 g (N = 6)	WCK 6777 4 g (N = 6)	ERT 3 g (N = 6)	ZID 3 g (N = 6)	WCK 6777 6 g (N = 6)	Placebo (N = 10)	All participants (N = 52)
At least one adverse event	6 (100)	6 (100)	5 (83)	5 (83)	4 (67)	2 (33)	4 (67)	9 (90)	41 (79)
At least one related adverse event	4 (67)	6 (100)	4 (67)	5 (83)	2 (33)	2 (33)	4 (67)	8 (80)	35 (67)
Mild (Grade 1)	3 (50)	5 (83)	4 (67)	4 (67)	1 (17)	2 (33)	4 (67)	7 (70)	30 (58)
Moderate (Grade 2)	1 (17)	1 (17)	0	1 (17)	1 (17)	0	0	1 (10)	5 (10)
Severe (Grade 3)	0	0	0	0	0	0	0	0	0
At least one severe (Grade 3) unsolicited adverse event	0	0	0	0	0	0	0	0	0
Related	0	0	0	0	0	0	0	0	0
Unrelated	0	0	0	0	0	0	0	0	0
At least one serious adverse event	0	0	0	0	0	0	0	0	0
At least one related serious adverse event	0	0	0	0	0	0	0	0	0
Adverse event leading to early terminationc	0	0	0	0	0	0	0	0	0

^a ERT, ertapenem; ZID, zidebactam; and WCK 6777, ertapenem/zidebactam.

^b Values are n (%). N, number of participants in the safety population.

^c As reported on the Adverse Event electronic case report form. Participants are counted once per category regardless of the number of events.