In Table 4, the value at column 5, row 15 should have been 4 instead of 2. The corrected table is below.
Table 4.
Summary of treatment-emergent adverse events
| Number of subjects (%) | |||||
|---|---|---|---|---|---|
|
|
|||||
| MF/F 200/10 μg bid (n = 207) | MF/F 400/10 μg bid (n = 217) | MF 400 μg bid (n = 210) | F 10 μg bid (n = 209) | Placebo bid (n = 212) | |
| Treatment period (weeks 1–26) | |||||
| Any AE | 62 (30.0) | 57 (26.3) | 62 (29.5) | 70 (33.5) | 67 (31.6) |
| Severe or life-threatening AEs | 6 (2.9) | 9 (4.1) | 15 (7.1) | 16 (7.7) | 12 (5.7) |
| Life-threatening AEs | 0 | 4 (1.8) | 4 (1.9) | 4 (1.9) | 3 (1.4) |
| Serious AEs | 8 (3.9) | 16 (7.4) | 15 (7.1) | 17 (8.1) | 12 (5.7) |
| Discontinuations due to AEs | 2 (1.0) | 10 (4.6) | 9 (4.3) | 6 (2.9) | 8 (3.8) |
| Deaths | 1 (0.4) | 1 (0.4) | 3 (1.4) | 3 (1.4) | 1 (0.4) |
| Pneumonia | 1 (0.5) | 2 (0.9) | 0 | 2 (1.0) | 1 (0.5) |
| Treatment-related AEs | 9 (4.3) | 13 (6.0) | 12 (5.7) | 15 (7.2) | 10 (4.7) |
| Treatment period + safety extension (weeks 1–52) | |||||
| Any AE | 78 (37.7) | 78 (35.9) | 86 (41.07) | 88 (42.1) | |
| Severe or life-threatening AEs | 7 (3.4) | 21 (9.7) | 19 (9.0) | 24 (11.5) | |
| Life-threatening AEs | 1 (0.5) | 6 (2.8) | 4 (1.9) | 6 (2.9) | |
| Serious AEs | 13 (6.3) | 29 (13.4) | 22 (10.5) | 29 (13.9) | |
| Discontinuations due to AEs | 4 (1.9) | 14 (6.5) | 13 (6.2) | 11 (5.3) | |
| Deaths | 1 (0.4) | 3 (1.3) | 3 (1.4) | 8 (3.8) | |
| Pneumonia | 1 (0.5) | 4 (1.8) | 2 (1.0) | 4 (1.9) | |
| Treatment-related AEs | 12 (5.8) | 18 (8.3) | 15 (7.1) | 17 (8.1) | |
Abbreviations: AE, adverse event; bid, twice daily; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination.