Table 2.

Comparison of efficacy endpoints.

Clinical endpoints	ABW, n (%)	AdjBW, n (%)	Risk difference (90% confidence interval)	Two one-sided tests p values
				Lower margin	Upper margin	Conclusion
Clinical failurea	1 (2.0)	3 (6.1)	3.9 (– 2.4 to 10.6)	<0.0001	<0.0001	Equivalent
Developed resistance	1 (2.0)	2 (3.9)	1.9 (–3.6 to 7.5)	<0.0001	<0.0001	Equivalent
Antibiotic therapy modification	0 (0)	2(4)	4.0 (0.6 to 8.6)	<0.0001	<0.0001	Equivalent
90-day mortality	3 (6.0)	2 (3.9)	−2.1 (–9.2 to 5.0)	0.0014	<0.0001	Equivalent
90-day readmission	10 (20.0)	5 (9.8)	−10.2 (–21.8 to 1.4)	0.2470	0.0002	Not equivalent

ABW: actual body weight; AdjBW: adjusted body weight.

A total of four patients met criteria for clinical failure; one patient met criteria based on both components of the definition; that is, antibiotic therapy was modified due to clinical signs and symptoms and subsequent cultures indicated development of antimicrobial resistance to daptomycin.

^aCombined developed resistance and antibiotic therapy modification.