MITT population | Early switch subpopulation | |
---|---|---|
(n = 250) | (n = 102) | |
Response | n/N (%) [95% CI]a | n/N (%) [95% CI]a |
Global response at EOT | ||
Success | 170/203 (83.7) [78.7–88.8] | 81/ 90 (90.0) [83.8–96.2] |
Sensitivity analysis* | 170/250 (68.0) [62.2–73.8] | 81/102 (79.4) [71.6–87.3] |
Failure | 33 | 9 |
Missing/unknown | 47 | 12 |
Clinical response at EOT | ||
Success | 174/187 (93.0) [89.4–96.7] | 83/ 89 (93.3) [88.0–98.5] |
Sensitivity analysis* | 174/250 (69.6) [63.9–75.3] | 83/102 (81.4) [73.8–88.9] |
Failure | 13 | 6 |
Missing/unknown | 63 | 13 |
Microbiological response at EOT | ||
Success | 183/192 (95.3) [92.3–98.3] | 87/ 90 (96.7) [93.0–100.0] |
Sensitivity analysis* | 183/250 (73.2) [67.7–78.7] | 87/102 (85.3) [78.4–92.2] |
Failure | 9 | 3 |
Missing/unknown | 58 | 12 |
Global response at secondary time points | n/N (%) [95% CI] | n/N (%) [95% CI] |
EOIV | 208/235 (88.5) [84.4–92.6] | 97/101 (96.0) [92.2–99.8] |
Sensitivity analysis* | 208/250 (83.2) [78.6–87.8] | 97/102 (95.1) [90.9–99.3] |
Week 2 follow-up | 148/194 (76.3) [70.3–82.3] | 72/ 86 (83.7) [75.9–91.5] |
Sensitivity analysis* | 148/250 (59.2) [53.1–65.3] | 72/102 (70.6) [61.7–79.4] |
EOS | 131/187 (70.1) [63.5–76.6] | 68/ 86 (79.1) [70.5–87.7] |
Sensitivity analysis* | 131/250 (52.4) [46.2–58.6] | 68/102 (66.7) [57.5–75.8] |