Table A5.
FEV1 mean change from study baseline in Study 2 (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 | 54 | 53 | 48 | ||
| FEV1, L | 2.183 | 2.206 | 2.111 | 0.07 (−0.18, 0.32) | 0.09 (−0.16, 0.35) | |
| Week 1 | N | 53 | 49 | 48 | ||
| Mean Δ | 0.011 | 0.054 | 0.024 | −0.01 (−0.09, 0.07) | 0.03 (−0.05, 0.11) | |
| Week 6 | N | 52 | 51 | 47 | ||
| Mean Δ | −0.006 | 0.023 | 0.054 | −0.06 (−0.16, 0.04) | −0.03 (−0.13, 0.07) | |
| Week 12 | N | 47 | 49 | 42 | ||
| Mean Δ | −0.035 | 0.072 | 0.060 | −0.09 (−0.20, 0.01) | 0.01 (−0.09, 0.12) | |
| Week 13 | N | 39 | 31 | 36 | ||
| Mean Δ | −0.001 | 0.033 | 0.083 | −0.08 (−0.20, 0.03) | −0.05 (−0.18, 0.08) | |
| Week 18 | N | 47 | 41 | 43 | ||
| Mean Δ | −0.055 ** | 0.059 | 0.139 | −0.19 (−0.32, −0.07) | −0.08 (−0.21, 0.05) | |
| Week 19 | N | 9 | 14 | 6 | ||
| Mean Δ | −0.056 | 0.214 | 0.140 | −0.20 (−0.57, 0.18) | 0.07 (−0.28, 0.42) | |
| Week 24 | N | 46 | 43 | 43 | ||
| Mean Δ | 0.000 | 0.023 | 0.071 | −0.07 (−0.19, 0.05) | −0.05 (−0.17, 0.08) | |
| Week 30 | N | 50 | 47 | 42 | ||
| Mean Δ | 0.007 | 0.035 | 0.048 | −0.04 (−0.16, 0.08) | −0.01 (−0.14, 0.11) | |
Notes: ** p-value ≤ 0.01, 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.