Table 2.
Forced vital capacity (FVC) mean change from study baseline in Study 1 (observed data, double-blind placebo controlled (DBPC) Population a).
| Treatment Group: | 360 U | 240 U | Placebo | 360 U vs. Placebo Difference b 95% CI c |
240 U vs. Placebo Difference 95% CI |
|
|---|---|---|---|---|---|---|
| Study Baseline | N | 37 | 35 | 36 | ||
| FVC, L | 2.772 | 3.032 | 2.958 | −0.19 (−0.58, 0.21) | 0.07 (−0.32, 0.47) | |
| Week 1 | N | 37 | 35 | 35 | ||
| Mean Δ | −0.001 | −0.002 | 0.114 | −0.12 (−0.27, 0.04) | −0.12 (−0.28, 0.04) | |
| Week 3 | N | 35 | 35 | 31 | ||
| Mean Δ | 0.047 | −0.057 * | 0.110 | −0.06 (−0.22, 0.09) | −0.17 (−0.32, −0.01) | |
| Week 6 | N | 37 | 33 | 36 | ||
| Mean Δ | 0.003 | 0.029 | 0.126 | −0.12 (−0.25, 0.01) | −0.10 (−0.23, 0.04) | |
| Week 12 | N | 34 | 33 | 27 | ||
| Mean Δ | −0.006 * | 0.054 | 0.167 | −0.17 (−0.33, −0.02) | −0.11 (−0.27, 0.04) | |
| Week 13 | N | 33 | 32 | 25 | ||
| Mean Δ | 0.039 | 0.112 | 0.109 | −0.07 (−0.24, 0.10) | −0.10 (−0.27, 0.08) | |
| Week 15 | N | 33 | 30 | 28 | ||
| Mean Δ | −0.025 | 0.051 | 0.090 | −0.11 (−0.26, 0.03) | −0.04 (−0.19, 0.11) | |
| Week 18 | N | 37 | 33 | 30 | ||
| Mean Δ | −0.022 | 0.058 | 0.087 | −0.11 (−0.26, 0.05) | −0.03 (−0.19, 0.13) | |
Notes: * p-value ≤ 0.05 for onabotA vs. placebo. Results for imputed data are consistent with the observed data. a DBPC Population: these patients received at least one dose of study medication in the DBPC study period. b Differences are active treatment minus placebo in least-squares means from a one-way ANOVA model at each visit with treatment as a main effect. c 95% confidence intervals (CI) for the differences (active treatment minus placebo) are from pairwise contrasts from a one-way ANOVA model at each visit with treatment as a main effect.