Table 2.
Summary of adverse events (safety analysis set)
| AE | SYGMA 1 + SYGMA 2 pooled safety population | SYGMA 1 | |||
|---|---|---|---|---|---|
| As-needed budesonide-formoterol 200/6 μg (n = 3366) |
Budesonide maintenance 200 μg bid (n = 3369) |
Total (n = 6735) |
As-needed budesonide-formoterol 200/6 μg (n = 1277) |
As-needed terbutaline 0.5 mg (n = 1277) |
|
| Any AE | 1372 (40.8) | 1431 (42.5) | 2803 (41.6) | 485 (38.0) | 545 (42.7) |
| Any AE with an outcome of death | 1 (< 0.1) | 3 (< 0.1) | 4 (< 0.1) | 0 | 0 |
| Any SAE | 104 (3.1) | 110 (3.3) | 214 (3.2) | 38 (3.0) | 50 (3.9) |
| Any AE leading to discontinuation | 24 (0.7) | 38 (1.1) | 62 (0.9) | 10 (0.8) | 37 (2.9) |
All data are n (%)
AE adverse event, bid twice daily, SAE serious adverse event