Table 5.
Overview of Adverse Events, Safety Population
| |
Treatment group |
|||
|---|---|---|---|---|
| Fluticasone/formoterol 100/10 μg b.i.d. N = 118 | Fluticasone 100 μg b.i.d. N = 119 | Formoterol 10 μg b.i.d. N = 120 | Placebo b.i.d. N = 118 | |
| Any AE, n (%) |
38 (32.2) |
47 (39.5) |
44 (36.7) |
46 (39.0) |
| Any serious AE, n (%) |
1 (0.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Any severe AE, n (%) |
6 (5.1) |
6 (5.0) |
11 (9.2) |
16 (13.6) |
| Any AE leading to study discontinuationa, n (%) |
4 (3.4) |
5 (4.2) |
9 (7.5) |
17 (14.4) |
| Any AE with probably or possible relationship to study drug, n (%) |
5 (4.2) |
9 (7.6) |
10 (8.3) |
12 (10.2) |
| Any AE leading to death, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
|
Treatment-emergent AEs reported for >2% of patients in any treatment group, n (%) | ||||
| Infections and infestations |
20 (16.9) |
27 (22.7) |
14 (11.7) |
15 (12.7) |
| Upper respiratory tract infection |
7 (5.9) |
6 (5.0) |
3 (2.5) |
4 (3.4) |
| Nasopharyngitis |
3 (2.5) |
9 (7.6) |
3 (2.5) |
3 (2.5) |
| Urinary tract infection |
3 (2.5) |
3 (2.5) |
1 (0.8) |
1 (0.8) |
| Respiratory, thoracic and mediastinal disorders |
8 (6.8) |
8 (6.7) |
14 (11.7) |
17 (14.4) |
| Asthmab |
3 (2.5) |
4 (3.4) |
9 (7.5) |
14 (11.9) |
| Cough |
4 (3.4) |
2 (1.7) |
1 (0.8) |
1 (0.8) |
| Nervous system disorders |
5 (4.2) |
10 (8.4) |
6 (5.0) |
11 (9.3) |
| Headache |
2 (1.7) |
6 (5.0) |
3 (2.5) |
9 (7.6) |
| Gastrointestinal disorders |
3 (2.5) |
5 (4.2) |
3 (2.5) |
5 (4.2) |
| Diarrhoea | 2 (1.7) | 0 (0.0) | 1 (0.8) | 3 (2.5) |
AEs = adverse events; N = total number of patients; n = number of patients in specified category; b.i.d. = twice daily.
Adverse events were coded using MedDRA™ version 9.0. At each level of summation (preferred term, system organ class and overall), each patient was counted only once. Percentages were based on the number of patients in the population for each treatment group.
a. Six of the 35 patients (1 fluticasone/formoterol, 1 fluticasone, 1 formoterol, and 3 placebo) had treatment-emergent adverse events reported as the primary reason for early discontinuation from the study. The remaining 29 patients (3 fluticasone/formoterol, 4 fluticasone, 8 formoterol, and 14 placebo) had lack of efficacy reported as the primary reason for early discontinuation from the study. A serious adverse event was one which resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, inpatient hospitalisation or prolongation of existing hospitalisation, congenital anomaly or birth defect, or an important medical event.
b. An exacerbation of asthma was considered as an adverse event if it did not resolve with the study drug, including rescue albuterol/salbutamol, and additional medication was required (e.g., systemic glucocorticosteroids).