Table 5.
Number and percentage of patients with decreases of ≥12% and ≥200 mL in FVC or FEV1 for Study 2 (observed data).
| Population: | DBPC Population a | Population 2 b | Population 3 c | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Group: | 360 U | 240 U | Placebo | 360 U | 240 U | Placebo | 360 U | 240 U | Placebo | |
| Week 1 | N | 53 | 49 | 48 | 41 | 30 | 37 | 9 | 15 | 7 |
| n (%) | 6 (11.3) | 7 (14.3) | 5 (10.4) | 4 (9.8) | 3 (10.0) | 4 (10.8) | 1 (11.1%) | 2 (13.3%) | 1 (14.3%) | |
| Week 6 | N | 52 | 51 | 47 | 41 | 32 | 37 | 9 | 15 | 7 |
| n (%) | 8 (15.4) | 5 (9.8) | 5 (10.6) | 7 (17.1) | 4 (12.5) | 3 (8.1) | 1 (11.1%) | 1 (6.7%) | 2 (28.6%) | |
| Week 12 | N | 47 | 49 | 42 | 37 | 31 | 35 | 9 | 15 | 6 |
| n (%) | 9 (19.1) | 4 (8.2) | 4 (9.5) | 8 (21.6) * | 1 (3.2) | 1 (2.9) | 1 (11.1%) | 2 (13.3%) | 3 (50.0%) | |
| Week 13 | N | 39 | 31 | 36 | 39 | 31 | 36 | -- | -- | -- |
| n (%) | 9 (23.1) | 3 (9.7) | 3 (8.3) | 9 (23.1) | 3 (9.7) | 3 (8.3) | -- | -- | -- | |
| Week 18 | N | 47 | 41 | 43 | 37 | 27 | 36 | 9 | 12 | 7 |
| n (%) | 11 (23.4) | 6 (14.6) | 4 (9.3) | 8 (21.6) * | 5 (18.5) | 1 (2.8) | 3 (33.3%) | 1 (8.3%) | 3 (42.9%) | |
| Week 19 | N | 9 | 14 | 6 | -- | -- | -- | 9 | 14 | 6 |
| n (%) | 2 (22.2%) | 1 (7.1%) | 1 (16.7%) | -- | -- | -- | 2 (22.2%) | 1 (7.1%) | 1 (16.7%) | |
| Week 24 | N | 46 | 43 | 43 | 38 | 30 | 36 | 8 | 12 | 7 |
| n (%) | 10 (21.7) * | 6 (14.0) | 3 (7.0) | 9 (23.7) * | 5 (16.7) | 2 (5.6) | 1 (12.5%) | 1 (8.3%) | 1 (14.3%) | |
| Week 30 | N | 50 | 47 | 42 | 40 | 31 | 36 | 9 | 15 | 6 |
| n (%) | 9 (18.0) | 8 (17.0) | 5 (11.9) | 7 (17.5) | 7 (22.6) | 5 (13.9) | 2 (22.2%) | 1 (6.7%) | 0 (0.0%) | |
* p-value ≤ 0.05 for onabotA vs. placebo. a DBPC Population: these patients received at least one dose of study medication in the DBPC study period. b Population 2: these patients received their second injection of study medication 12 weeks after the first. c Population 3: these patients received their second injection of study medication 18 weeks after the first. Shaded columns indicate that “population 2” are separate from the DBPC population.