Patients with AEs (>2.0%) by preferred term and SAEs occurring in high-dose MF/IND one time a day and high-dose FLU/SAL two times a day groups
| Preferred term | High-dose MF/IND (320/150 µg) one time a day n=1056 | High-dose FLU/SAL (500/50 µg) two times a day n=1062 |
| AEs, n (%) | ||
| Patients with at least one AE | 740 (70.1) | 777 (73.2) |
| Asthma | 369 (34.9) | 446 (42.0) |
| Nasopharyngitis | 123 (11.6) | 130 (12.2) |
| Upper respiratory tract infection | 74 (7.0) | 90 (8.5) |
| Headache | 50 (4.7) | 47 (4.4) |
| Bronchitis | 66 (6.3) | 72 (6.8) |
| Back pain | 27 (2.6) | 22 (2.1) |
| Respiratory tract infection viral | 21 (2.0) | 35 (3.3) |
| Influenza | 35 (3.3) | 40 (3.8) |
| Hypertension | 24 (2.3) | 29 (2.7) |
| Pharyngitis | 30 (2.8) | 34 (3.2) |
| Rhinitis | 27 (2.6) | 20 (1.9) |
| Viral upper respiratory tract infection | 45 (4.3) | 68 (6.4) |
| Cough | 19 (1.8) | 23 (2.2) |
| Rhinitis allergic | 14 (1.3) | 27 (2.5) |
| Upper respiratory tract infection bacterial | 32 (3.0) | 37 (3.5) |
| Lower respiratory tract infection | 17 (1.6) | 30 (2.8) |
| Patient with at least one AE leading to permanent discontinuation of study drug, n (%) | 27 (2.6) | 32 (3.0) |
| SAEs, n (%) | ||
| Patients with at least one SAE | 73 (6.9) | 60 (5.6) |
| Asthma | 15 (1.4) | 11 (1.0) |
| Acute myocardial infarction | 3 (0.3) | 2 (0.2) |
| Pneumonia | 2 (0.2) | 5 (0.5) |
| Lower respiratory tract infection | 3 (0.3) | 2 (0.2) |
| Atrial fibrillation | 1 (0.1) | 2 (0.2) |
| Peritonitis | 1 (0.1) | 3 (0.3) |
| Death, n (%) | 4 (0.4) | 0 |
A patient with multiple AEs with the same preferred term is counted only once for that preferred term. Only AEs reported while on study drug or within 7 days of the last dose (within 30 days for SAEs) are included.
AE, adverse event; FLU/SAL, fluticasone propionate/salmeterol xinafoate; MF/IND, mometasone furoate/indacaterol acetate; n, number of patients; SAE, serious adverse event.