Table 5.

Effect of POD+death on sample size estimates

Choice of primary outcome (effect size)	Number required per group
POD + death at 28 days (25% RRR from 46.0%)	286
28-day mortality (25% RRR from 27.2%)	616
VFD at 28-days with SD = 10.2
(1 day difference)	1,635
(2 day difference)	410
(3 day difference)	183
(4 day difference)	104
(5 day difference)	67
OFFD at 28 days with SD = 11.6
(1 day difference)	2,114
(2 day difference)	530
(3 day difference)	236
(4 day difference)	133
(5 day difference)	86

Projected sample sizes required to achieve 80% power at a two-sided alpha = 0.05 using control rates and standard deviations observed for the REDOXS Study with arbitrary but typical effect sizes.

OFFD, organ failure free days; POD, Persistent Organ Dysfunction Score; VFD, ventilator-free days.