Table 3.
FVC 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 | ||
| FVC, L | 2.935 | 3.053 | 2.889 | 0.05 (−0.27, 0.36) | 0.16 (−0.15, 0.48) | |
| Week 1 | N | 53 | 49 | 48 | ||
| Mean Δ | 0.020 | 0.085 | −0.001 | 0.02 (−0.08, 0.13) | 0.09 (−0.02, 0.19) | |
| Week 6 | N | 52 | 51 | 47 | ||
| Mean Δ | −0.078 * | 0.052 | 0.049 | −0.13 (−0.24, −0.01) | 0.00 (−0.11, 0.12) | |
| Week 12 | N | 47 | 49 | 42 | ||
| Mean Δ | −0.040 | 0.100 | 0.029 | −0.07 (−0.20, 0.06) | 0.07 (−0.06, 0.20) | |
| Week 13 | N | 39 | 31 | 36 | ||
| Mean Δ | −0.060 ** | 0.084 | 0.119 | −0.18 (−0.31, −0.05) | −0.03 (−0.17, 0.11) | |
| Week 18 | N | 47 | 41 | 43 | ||
| Mean Δ | −0.128 *** | 0.064 | 0.080 | −0.21 (−0.33, −0.09) | −0.02 (−0.14, 0.11) | |
| Week 19 | N | 9 | 14 | 6 | ||
| Mean Δ | −0.064 | 0.189 | 0.025 | −0.09 (−0.51, 0.33) | 0.16 (−0.23, 0.56) | |
| Week 24 | N | 46 | 43 | 43 | ||
| Mean Δ | −0.082 *** | 0.094 | 0.149 | −0.23 (−0.37, −0.09) | −0.05 (−0.20, 0.09) | |
| Week 30 | N | 50 | 47 | 42 | ||
| Mean Δ | −0.046 | 0.088 | 0.061 | −0.11 (−0.24, 0.02) | 0.03 (−0.11, 0.16) | |
***, **, * p-value ≤ 0.001, 0.01, 0.05, respectively, for onabotA vs. placebo. 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.