TABLE 5.
Proportion of subjects with favorable clinical 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 | |
| ME population | |||||
| DCIV | 96.3 (78/81) | 98.8 (85/86) | 95.2 (79/83) | 1.1 (−6.2 to 8.6)* | 3.7 (−2.0 to 10.8)* |
| EFU | 94.9 (75/79) | 94.2 (81/86) | 96.3 (78/81) | −1.4 (−9.1 to 6.0) | −2.1 (−9.7 to 5.3) |
| LFU | 93.7 (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 | |||||
| DCIV | 89.9 (80/89) | 91.7 (88/96) | 90.2 (83/92) | −0.3 (−9.6 to 8.9)§ | 1.4 (−7.2 to 10.3)* |
| EFU | 86.5 (77/89) | 88.5 (85/96) | 89.1 (82/92) | −2.6 (−12.7 to 7.2) | −0.6 (−10.0 to 8.9) |
| LFU | 87.6 (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.)