TABLE 6

Commonly occurring treatment-emergent AEs that occurred in >10% of subjects during multiple-dose treatment

AENo. (%) of subjects positive/no. of events
Pooled placebo (n = 16)Pooled meropenem alone (n = 19)Vaborbactam alone (n = 8)Pooled meropenem/vaborbactam combination (n = 37)
>1 TEAE12 (75.0)/1918 (94.7)/396 (75.0)/1126 (70.3)/67
Infusion site phlebitis4 (25.0)/47 (36.8)/72 (25.0)/323 (62.2)/44
Infusion site pain2 (12.5)/33 (15.8)/3013 (35.1)/16
Infusion site erythema3 (18.8)/35 (26.3)/703 (8.1)/3
Infusion site swelling3 (18.8)/31 (5.3)/203 (8.1)/4
Vessel puncture site hematoma2 (12.5)/2005 (13.5)/5
Fatigue01 (5.3)/11 (12.5)/11 (2.7)/1
Catheter site hematoma04 (21.1)/404 (10.8)/4
Catheter site erythema2 (12.5)/2002 (5.4)/2
Catheter site pain0004 (10.8)/4
Catheter site phlebitis002 (25.0)/22 (5.4)/2
Headache2 (12.5)/26 (31.6)/92 (25.0)/38 (21.6)/10
Diarrhea02 (10.5)/201 (2.7)/1
Erythema003 (37.5)/30
Infusion site cellulitis02 (10.5)/200
Decreased appetite02 (10.5)/200