|  | FDC | FDC | Aclidinium | Formoterol |
---|---|---|---|---|---|
 | Placebo | 400/12 μg | 400/6 μg | 400 μg | 12 μg |
n (%) | (n = 194) | (n = 385) | (n = 381) | (n = 385) | (n = 384) |
Any TEAE | 103 (53.1) | 194 (50.4) | 193 (50.7) | 190 (49.4) | 217 (56.5) |
TEAEs in ≥2% of any treatment group (by preferred term) |  |  |  |  | |
 COPD exacerbation | 27 (13.9) | 36 (9.4) | 38 (10.0) | 46 (11.9) | 60 (15.6) |
 Headache | 16 (8.2) | 29 (7.5) | 27 (7.1) | 35 (9.1) | 43 (11.2) |
 Nasopharyngitis | 14 (7.2) | 30 (7.8) | 30 (7.9) | 22 (5.7) | 26 (6.8) |
 Back pain | 9 (4.6) | 18 (4.7) | 13 (3.4) | 20 (5.2) | 19 (4.9) |
 Diarrhoea | 5 (2.6) | 6 (1.6) | 5 (1.3) | 2 (0.5) | 6 (1.6) |
 Nausea | 5 (2.6) | 3 (0.8) | 4 (1.0) | 4 (1.0) | 1 (0.3) |
 Abdominal pain, upper | 4 (2.1) | 2 (0.5) | 3 (0.8) | 4 (1.0) | 6 (1.6) |
 Arthralgia | 3 (1.5) | 6 (1.6) | 3 (0.8) | 3 (0.8) | 12 (3.1) |
 URTI | 3 (1.5) | 8 (2.1) | 4 (1.0) | 7 (1.8) | 10 (2.6) |
 Hypertension | 2 (1.0) | 3 (0.8) | 4 (1.0) | 2 (0.5) | 9 (2.3) |
 Sinusitis | 1 (0.5) | 3 (0.8) | 10 (2.6) | 3 (0.8) | 3 (0.8) |
 Rhinitis | 1 (0.5) | 2 (0.5) | 6 (1.6) | 2 (0.5) | 10 (2.6) |
 Oropharyngeal pain | 1 (0.5) | 10 (2.6) | 2 (0.5) | 5 (1.3) | 2 (0.5) |
TEAEs leading to discontinuation | 8 (4.1) | 16 (4.2) | 12 (3.1) | 17 (4.4) | 14 (3.6) |
TESAEs | 12 (6.2) | 23 (6.0) | 18 (4.7) | 16 (4.2) | 14 (3.6) |
TESAEs occurring in >2 patients in any treatment group (by preferred term) | Â | Â | Â | Â | Â |
 COPD exacerbation | 5 (2.6) | 4 (1.0) | 4 (1.0) | 7 (1.8) | 1 (0.3) |
 Pneumonia | 1 (0.5) | 3 (0.8) | 4 (1.0) | 0 (0.0) | 0 (0.0) |