TABLE 5

Proportion of subjects with favorable clinical 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
ME population
    DCIV96.3 (78/81)98.8 (85/86)95.2 (79/83)1.1 (−6.2 to 8.6)*3.7 (−2.0 to 10.8)*
    EFU94.9 (75/79)94.2 (81/86)96.3 (78/81)−1.4 (−9.1 to 6.0)−2.1 (−9.7 to 5.3)
    LFU93.7 (74/79)95.3 (81/85)94.9 (75/79)−1.3 (−9.6 to 6.9)0.4 (−7.2 to 8.2)
MITT population
    DCIV89.9 (80/89)91.7 (88/96)90.2 (83/92)−0.3 (−9.6 to 8.9)§1.4 (−7.2 to 10.3)*
    EFU86.5 (77/89)88.5 (85/96)89.1 (82/92)−2.6 (−12.7 to 7.2)−0.6 (−10.0 to 8.9)
    LFU87.6 (78/89)89.6 (86/96)85.9 (79/92)1.8 (−8.5 to 12.0)3.7 (−5.9 to 13.6)
  • a n/m, number of subjects with favorable clinical response/number of subjects with clinical response assessment; CI, confidence interval; DCIV, discontinuation of i.v. therapy; EFU, early follow-up (5 to 9 days after completion of i.v. study therapy); LFU, late follow-up (28 to 42 days after completion of i.v. study therapy).

  • b The 95% CIs for between-treatment differences and associated P values are based on the unconditional asymptotic Miettinen and Nurminen method without stratification. *, P < 0.001; §, P = 0.002. (A P value of <0.025 indicates REL plus IMI is noninferior to control.)