Table 8.

Safety Analysis

Variable	Sulopenem Etzadroxil/Probenecid (N = 833) n (%)	Ciprofloxacin (N= 827) n (%)
Any adverse event
ȃAny event, no. of patients (%)	208 (25.0)	116 (14.0)
ȃTotal no. of events	361	168
Treatment-related adverse event
ȃAny event, no. of patients (%)	207 (24.8)	115 (13.9)
ȃTotal no. of events	223	70
Serious adverse event, no. of patients (%)
ȃAny event	6 (0.7)	2 (0.2)
ȃTreatment-related event	1 (0.1)	0 (0.0)
Death, no. (%)	1 (0.1)	0 (0.0)
Treatment-limiting adverse event, no. of patients (%)	13 (1.6)	8 (1.0)
Most common treatment-related adverse event, no. of patients (%)
ȃDiarrhea	103 (12.4)	21 (2.5)
ȃNausea	32 (3.8)	30 (3.6)
ȃHeadache	18 (2.2)	18 (2.2)
ȃVomiting	13 (1.6)	11 (1.3)
ȃDizziness	9 (1.1)	5 (0.6)