Table 4.
Safety among the subgroups of patients with episodes of >6 inhalations/day of as-needed therapy in Study A and Study B
|
Study A (12-month assessment) |
Study B (6-month assessment) |
|||||
|---|---|---|---|---|---|---|
| BUD/FORM + terbutaline (n = 278) | BUD/FORM + formoterol (n = 228) | BUD/FORM maintenance and reliever therapy (n = 148) | SAL/FLU FD + terbutaline (n = 156) | BUD/FORM FD + terbutaline (n = 167) | BUD/FORM maintenance and reliever therapy (n = 124) | |
| Deaths, n (%) |
1 (<0.5) |
1 (<0.5) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
| Patients with an SAE, n (%) |
26 (9) |
25 (11) |
21 (14) |
13 (8) |
18 (11) |
6 (5) |
| Asthma-related SAE, n (%) |
15 (5) |
15 (7) |
8 (5) |
7 (4) |
5 (3) |
2 (2) |
| Patients with a DAE, n (%) |
12 (4) |
12 (5) |
2 (1) |
3 (2) |
6 (4) |
0 (0) |
| *Asthma-related DAEs, n (%) | 6 (2) | 9 (4) | 1 (1) | 3 (2) | 4 (2) | 0 (0) |
*An additional 10, 2 and 1 patients receiving: terbutaline, formoterol and budesonide/formoterol reliever regimen, respectively in Study A were withdrawn due to predefined asthma-related treatment failure/safety criteria.
DAE = adverse events leading to discontinuation from the study; BUD/FORM = budesonide/formoterol; FD = fixed-dose maintenance; SAE = serious adverse event; SAL/FLU = salmeterol/fluticasone.