TABLE 6.

Safety analysis (safety population)

Eventa	Values for patients receiving:
	Plazomicin at 10 mg/kg (n = 22)	Plazomicin at 15 mg/kg (n = 74)	Levofloxacin at 750 mg (n = 44)
No. (%) of patients with any AE	7 (31.8)	26 (35.1)	21 (47.7)
No. (%) of patients with the following AEs reported in ≥5% of patients in any treatment group:
Headache	2 (9.1)	6 (8.1)	3 (6.8)
Diarrhea	0 (0.0)	4 (5.4)	2 (4.5)
Vomiting	0 (0.0)	4 (5.4)	1 (2.3)
Nausea	0 (0.0)	4 (5.4)	0 (0.0)
Dizziness	0 (0.0)	4 (5.4)	0 (0.0)
No. (%) of patients with:
AE related to renal functionb	0 (0.0)	2 (2.7)	0 (0.0)
AE related to vestibular or cochlear functionc	0 (0.0)	2 (2.7)	1 (2.3)
AE related to study drug	2 (9.1)	15 (20.3)	12 (27.3)
AE leading to study drug discontinuation	0 (0.0)	4 (5.4)	1 (2.3)
Any serious AE	0 (0.0)	1 (1.4)	2 (4.5)
No. of patients with a ≥0.5-mg/dl increase in serum creatinine concn/total no. of patients tested (%):
At any time during the study	1/22 (4.5)	4/72 (5.6)	1/41 (2.4)
While on i.v. study drug	0/22 (0.0)	3/72 (4.2)	0/41 (0.0)

^aAEs were coded according to the preferred terms in version 12.1 of MedDRA.

^bEvents include preferred terms of azotemia and acute renal failure.

^cEvents include preferred terms of tinnitus and vertigo and worsening of audiometry.