Table 3 SAE/DAE data and analysis
Variable | Formoterol | Salbutamol | Odds ratio | P value |
|---|---|---|---|---|
(n = 1402) | (n = 1393) | (95 % CI) | ||
Total SAE and/or DAEs | 65 (4.6) | 76 (5.5) | 0.84 (0.60, 1.18) | 0.323 |
Serious adverse events | 53 (3.8) | 65 (4.7) | 0.80 (0.55, 1.16) | 0.245 |
Deaths | 2 (0.1) | 4 (0.3) | 0.50 (0.09, 2.71) | 0.419 |
Asthma-related SAE | 41 (2.9) | 51 (3.7) | 0.79 (0.52, 1.20) | 0.276 |
Non-asthma-related SAE | 12 (0.9) | 14 (1.0) | 0.85 (0.39, 1.85) | 0.682 |
Cardiovascular-related SAE | 1 (0.1) | 5 (0.4) | 0.20 (0.02, 1.70) | 0.140 |
Discontinuations due to AE | 15 (1.1) | 17 (1.2) | 0.88 (0.44, 1.76) | 0.709 |
Asthma-related DAE | 9 (0.6) | 4 (0.3) | 2.24 (0.69, 7.30) | 0.180 |
Non-asthma-related DAE | 6 (0.4) | 13 (0.9) | 0.46 (0.17, 1.20) | 0.113 |
SAE-related DAE | 3 (0.2) | 6 (0.4) | 0.50 (0.12, 1.99) | 0.322 |
Non-SAE-related DAE | 12 (0.9) | 11 (0.8) | 1.09 (0.48, 2.47) | 0.846 |