Table 4.

Renal Safety and Adverse Events

Event	No. (%)	Comment
Creatinine % change, mean	5.2% (95% CI, .20%–10.1%); range, (−6.7% to 21.3%)	…
Any AE	7 (53.8)	All mild to moderate
Serious AE	0 (0)	…
Headache	6 (46.2)	Pain (mean self-reported score, 5 out of 10; n = 4); Duration (n = 4): mean, 37 h (range, 1–72 h)
Hearing changes	1 (7.7)	Intermittent muffled hearing
Urine changes	1 (7.7)	Darker urine
Vomiting	1 (7.7)	One episode
Fatigue	2 (15.4)	Tired × 1 day

Data are presented as no. (%) unless otherwise indicated.

Abbreviations: AE, adverse event; CI, confidence interval.