TABLE 8.
Proportion of subjects in the ME population with favorable microbiological responsea
| Parameter | Result for treatment group, % (n/m) |
REL vs placebo comparison, % difference (95% CI)b |
|||
|---|---|---|---|---|---|
| 250 mg REL + IMI | 125 mg REL + IMI | Placebo + IMI | 250 mg REL + IMI | 125 mg REL + IMI | |
| DCIV | 97.6 (81/83) | 100 (86/86) | 97.6 (82/84) | −0.0 (−6.3 to 6.2) | 2.4 (−2.0 to 8.3) |
| EFU | 97.4 (76/78) | 97.6 (80/82) | 97.5 (78/80) | −0.1 (−6.7 to 6.4) | 0.1 (−6.3 to 6.5) |
| LFU | 96.2 (75/78) | 97.6 (80/82) | 96.2 (75/78) | 0.0 (−7.4 to 7.4) | 1.4 (−5.1 to 8.6) |
| GFU | 96.2 (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.