Table A4.
FEV1 mean change from study baseline in Study 1 (observed data, 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 | ||
| FEV1, L | 2.233 | 2.469 | 2.437 | −0.20 (−0.52, 0.11) | 0.03 (−0.29, 0.35) | |
| Week 1 | N | 37 | 35 | 35 | ||
| Mean Δ | −0.044 | −0.045 | 0.073 | −0.12 (−0.25, 0.01) | −0.12 (−0.25, 0.01) | |
| Week 3 | N | 35 | 35 | 31 | ||
| Mean Δ | −0.009 | −0.102 * | 0.059 | −0.07 (−0.22, 0.08) | −0.16 (−0.31, −0.01) | |
| Week 6 | N | 37 | 33 | 36 | ||
| Mean Δ | −0.038 * | −0.041 * | 0.102 | −0.14 (−0.26, −0.02) | −0.14 (−0.27, −0.02) | |
| Week 12 | N | 34 | 33 | 27 | ||
| Mean Δ | −0.029 | −0.066 | 0.033 | −0.06 (−0.20, 0.08) | −0.10 (−0.24, 0.04) | |
| Week 13 | N | 33 | 32 | 25 | ||
| Mean Δ | −0.035 | −0.093 | 0.028 | −0.06 (−0.25, 0.12) | −0.12 (−0.31, 0.06) | |
| Week 15 | N | 33 | 30 | 28 | ||
| Mean Δ | −0.042 | −0.120 | 0.024 | −0.07 (−0.22, 0.09) | −0.14 (−0.30, 0.01) | |
| Week 18 | N | 37 | 33 | 30 | ||
| Mean Δ | −0.059 | −0.137 | 0.018 | −0.08 (−0.23, 0.08) | −0.16 (−0.31, 0.00) | |
Note: * 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.