Table 4.
Number and percentage of patients with decreases of ≥12% and ≥200 mL in FVC or FEV1 for Study 1 (observed data).
| Population: | DBPC Population a | Population 2 b | |||||
|---|---|---|---|---|---|---|---|
| Treatment Group: | 360 U | 240 U | Placebo | 360 U | 240 U | Placebo | |
| Week 1 | N | 37 | 35 | 35 | 29 | 28 | 27 |
| n (%) | 6 (16.2%) | 4 (11.4%) | 6 (17.1%) | 5 (17.2%) | 3 (10.7%) | 3 (11.1%) | |
| Week 6 | N | 35 | 35 | 31 | 27 | 28 | 25 |
| n (%) | 5 (14.3%) | 8 (22.9%) | 3 (9.7%) | 4 (14.8%) | 6 (21.4%) | 3 (12.0%) | |
| Week 12 | N | 37 | 33 | 36 | 29 | 28 | 28 |
| n (%) | 4 (10.8%) | 6 (18.2%) | 4 (11.1%) | 4 (13.8%) | 4 (14.3%) | 2 (7.1%) | |
| Week 13 | N | 34 | 33 | 27 | 29 | 28 | 25 |
| n (%) | 6 (17.6%) | 6 (18.2%) | 4 (14.8%) | 6 (20.7%) | 5 (17.9%) | 4 (16.0%) | |
| Week 18 | N | 33 | 32 | 25 | 26 | 27 | 23 |
| n (%) | 6 (18.2%) | 7 (21.9%) | 4 (16.0%) | 4 (15.4%) | 5 (18.5%) | 4 (17.4%) | |
| Week 24 | N | 33 | 30 | 28 | 27 | 24 | 25 |
| n (%) | 5 (15.2%) | 7 (23.3%) | 5 (17.9%) | 4 (14.8%) | 5 (20.8%) | 4 (16.0%) | |
| Week 30 | N | 37 | 33 | 30 | 29 | 27 | 27 |
| n (%) | 6 (16.2%) | 8 (24.2%) | 5 (16.7%) | 4 (13.8%) | 6 (22.2%) | 4 (14.8%) | |
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. Shaded columns indicate that “population 2” are separate from the DBPC population.