Table 2.

MEDI3902 phase II EVADE: efficacy through study day 22 (mITT)

	MEDI3902 500 mg (N = 16)	MEDI3902 1500 mg (N = 85)	Placebo (N = 83)	RRRa	80% CIa	P valuea
Primary endpoint
P. aeruginosa Pneumonia	2 (12.5%)	19 (22.4%)	15 (18.1%)	− 23.7%	− 83.8 to 16.8%	0.491
Exploratory endpoints of interest (FDA)
All-cause pneumoniab	3 (18.8%)	25 (29.4%)	17 (20.5%)	− 43.6%	− 104 to -1.1%	0.186
All-cause pneumonia or deathc	4 (25.0%)	30 (35.3%)	22 (26.5%)	− 33.2%	− 79.8 to 1.4%	0.222

RRR: relative risk reduction (a negative RRR denotes more PA pneumonia in the MEDI3902 1500 mg group compared to placebo); mITT = modified intent-to-treat population

All pneumonias were determined by an adjudication committee

^aRelative risk reduction (MEDI3902 1500 mg vs. placebo), 80% confidence interval (CI), and p value based on Poisson regression with robust variance

^bAll-cause pneumonia: P. aeruginosa pneumonia or non-P. aeruginosa pneumonia occurring through study day 22

^cAll-cause pneumonia or death: P. aeruginosa pneumonia, non-P. aeruginosa pneumonia, or death occurring through study day 22