Table 1.

Treatment-related adverse events in randomized and treated patients in phase II/III clinical development program

Studies	Dalbavancin			Comparator
	N	Two dosesa	One doseb	N	Regimen
All phase II/III studies	1778	1428	350	1224
Phase II studies	81	54	27	55
Catheter-related bloodstream infections
VER001-4 [11]	40	34	6	34	Vancomycin
Skin and skin structure infections
VER001-5 [9]	41	20	21c	21	Standard of care
Phase III studies	1697	1374	323	1169
Uncomplicated skin and skin structure infection
VER001-8 (Data on file, Allergan plc.) [16]	367	94	273	186	Cefazolin
Complicated skin and skin structure infection
VER001-16 (Data on file, Allergan plc.) [16]	107	57	50	49	Vancomycin
VER001-9 [8]	571	571	0	283	Linezolid
Acute bacterial skin and skin structure infection
DUR001-301 (DISCOVER 1) [10]	284	284	0	284	Vancomycin/linezolid
DUR001-302 (DISCOVER 2) [10]	368	368	0	367	Vancomycin/linezolid

Comparator agents include cephalosporins, vancomycin, oxacillin, nafcillin and linezolid. Studies VER001-4, 5, and 16 were open-label trials; all others were double blinded. DISCOVER 1 and DISCOVER 2 ClinicalTrials.gov numbers, NCT01339091 and NCT01431339

^aIntravenous dalbavancin 1000 mg on day 1 followed by 500 mg on day 8

^bIntravenous dalbavancin 1000 mg on day 1

^cIntravenous dalbavancin 1100 mg