TABLE 8

Proportion of subjects in the ME population with favorable microbiological responsea

ParameterResult for treatment group, % (n/m)REL vs placebo comparison, % difference (95% CI)b
250 mg REL + IMI125 mg REL + IMIPlacebo + IMI250 mg REL + IMI125 mg REL + IMI
DCIV97.6 (81/83)100 (86/86)97.6 (82/84)−0.0 (−6.3 to 6.2)2.4 (−2.0 to 8.3)
EFU97.4 (76/78)97.6 (80/82)97.5 (78/80)−0.1 (−6.7 to 6.4)0.1 (−6.3 to 6.5)
LFU96.2 (75/78)97.6 (80/82)96.2 (75/78)0.0 (−7.4 to 7.4)1.4 (−5.1 to 8.6)
GFU96.2 (75/78)97.5 (79/81)96.2 (75/78)0.0 (−7.4 to 7.4)1.4 (−5.2 to 8.6)
  • a Subjects with indeterminate or missing response were excluded (2 at DCIV, 8 at EFU, 8 at GFU, and 8 at LFU). CI, confidence interval; DCIV, discontinuation of i.v. therapy; EFU, early follow-up; GFU, global follow-up; LFU, late follow-up; n/m, number of subjects with favorable microbiological response/number of ME subjects included in the analysis.

  • b The 95% confidence intervals of between-treatment differences are based on the unconditional asymptotic Miettinen and Nurminen method without stratification.