Table A3.
FVC mean change from study baseline in Studies 1 and 2 for Population 2 (both studies) and Population 3 (Study 2 only).
| Population: | Population 2 a | Population 3 b | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study: | Study 1 | Study 2 | Study 2 | |||||||
| Treatment Group: | 360 U | 240 U | Pbo | 360 U | 240 U | Pbo | 360 U | 240 U | Pbo | |
| Study Baseline | N | 29 | 28 | 28 | 41 | 32 | 37 | 9 | 15 | 7 |
| FVC, mL | 2830 | 3032 | 2981 | 2935 | 3179 | 2955 | 3087 | 2788 | 2574 | |
| Week 1 | N | 29 | 28 | 27 | 41 | 30 | 37 | 9 | 15 | 7 |
| Mean Δ | −3 | 25 | 165 | 35 | 87 | −6 | −22 | 115 | −23 | |
| Week 3 | N | 27 | 28 | 25 | -- | -- | -- | -- | -- | -- |
| Mean Δ | 51 | −20 | 130 | -- | -- | -- | -- | -- | -- | |
| Week 6 | N | 29 | 28 | 28 | 41 | 32 | 37 | 9 | 15 | 7 |
| Mean Δ | −11 ** | 30 | 177 | −69 | 33 | 43 | −122 | 72 | −51 | |
| Week 12 | N | 29 | 28 | 25 | 37 | 31 | 35 | 9 | 15 | 6 |
| Mean Δ | −11 ** | 37 | 170 | −50 | 66 | 80 | −18 | 163 * | −275 | |
| Week 13 | N | 26 | 27 | 23 | 39 | 31 | 36 | -- | -- | -- |
| Mean Δ | 42 | −5 | 103 | −60 ** | 84 | 119 | -- | -- | -- | |
| Week 15 | N | 27 | 24 | 25 | -- | -- | -- | -- | -- | -- |
| Mean Δ | −19 | 14 | 98 | -- | -- | -- | -- | -- | -- | |
| Week 18 | N | 29 | 27 | 27 | 37 | 27 | 36 | 9 | 12 | 7 |
| Mean Δ | −21 | 8 | 89 | −132 *** | 31 | 112 | −127 | 110 | −83 | |
| Week 19 | N | -- | -- | -- | -- | -- | -- | 9 | 14 | 6 |
| Mean Δ | -- | -- | -- | -- | -- | -- | −64 | 189 | 25 | |
| Week 24 | N | -- | -- | -- | 38 | 30 | 36 | 8 | 12 | 7 |
| Mean Δ | -- | -- | -- | −106 *** | 51 | 186 | 36 | 138 | −44 | |
| Week 30 | N | -- | -- | -- | 40 | 31 | 36 | 9 | 15 | 6 |
| Mean Δ | -- | -- | -- | −69 * | 57 | 73 | 31 | 123 | −10 | |
***, **, * p-value ≤ 0.001, 0.01, 0.05, respectively, for onabotA vs. placebo. Results for imputed data are consistent with the observed data. a Population 2: these patients received their second injection of study medication 12 weeks after the first. b Population 3: these patients received their second injection of study medication 18 weeks after the first.