A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study

Table 5 Safety parameters in the all-treated population

	Telavancin	Standard therapy
	(n = 29)	(n = 29)
Deaths	5 (17%)	3 (10%)
Serious adverse events	11 (38%)	6 (21%)
Discontinuing study drug due to an adverse event	2 (7%)	2 (7%)
≥1 adverse event	26 (90%)	21 (72%)
Adverse event ≥5% in any treatment arm
Pyrexia	4 (14%)	2 (7%)
Headache	3 (10%)	3 (10%)
Anemia	3 (10%)	2 (7%)
Rash^a	2 (7%)	3 (10%)
Deep vein thrombosis	3 (10%)	1 (3%)
Hypokalemia	3 (10%)	1 (3%)
Nausea	1 (3%)	3 (10%)
Vomiting	1 (3%)	3 (10%)
Catheter site erythema	2 (7%)	1 (3%)
Dysgeusia^b	3 (10%)	0
Agitation	2 (7%)	1 (3%)
Insomnia	2 (7%)	1 (3%)
Hematuria	1 (3%)	2 (7%)
Atelectasis	2 (7%)	1 (3%)
Dyspnea	1 (3%)	2 (7%)
Pruritus	1 (3%)	2 (7%)
Phlebitis	1 (3%)	2 (7%)
Urinary tract infection^c	4 (14%)	0
Acute renal failure	2 (7%)	0
Blood urea increased	2 (7%)	0
Eosinophilia^d	0	4 (14%)
Diarrhea	0	2 (7%)
Catheter site infection	0	2 (7%)

^aIncluding adverse events termed “rash,” “maculo-papular rash,” and “rash pruritic.”
^bUsually metallic taste.
^cIncluding adverse events termed “urinary tract infection fungal” and “urinary tract infection.”
^dIncluding adverse events termed “eosinophilia” and “eosinophil count increased.”

ISSN: 1471-2334