Table 2.
Overall summary of adverse events (safety population).
| Total (n = 2539) | |
|---|---|
| Patients with ⩾1 AE, n (%) | 1523 (60.0) |
| Number of AEs | 4264 |
| Patients with ⩾1 related* AE, n (%) | 258 (10.2) |
| Number of related* AEs | 375 |
| Patients with ⩾1 severe AE, n (%) | 319 (12.6) |
| Number of severe AEs | 508 |
| Patients with ⩾1 related* severe AE, n (%) | 29 (1.1) |
| Number of related* severe AEs | 36 |
| Patients with ⩾1 SAE, n (%) | 107 (4.2) |
| Number of SAEs | 139 |
| Patients who died$ | 4 (0.2) |
| Patients with ⩾1 AE | 152 (6.0) |
| Leading to study/treatment discontinuation‡ | 1223 (48.2) |
| Requiring additional therapy | 39 (1.5) |
| Leading to dose reduction | 28 (1.1) |
| Leading to dose interruption | 134 (5.3) |
| Leading to dose increase | |
| Patients with ⩾1 related* AE leading to study/treatment discontinuation‡ of special interest |
112 (4.4) 211 (8.3) |
*
Investigator considered reasonable possibility of causal relationship to investigational medicinal product.
$
Deaths were not considered to be possibly related to fluticasone/formoterol.
‡
An AE was considered as leading to discontinuation from study if other action taken contains ‘discontinued from observation’ or if action taken with fluticasone/formoterol is ‘withdrawn’.
Note that a patient may have findings in more than one category.
AE, adverse event; SAE, serious adverse event.