Table 2.
Most common treatment-emergent adverse events reported by >5.0% of patients in any treatment group.
| Treatment group (MDI-administered; BID) |
|||||
|---|---|---|---|---|---|
| MF/F | FP/S | MF/F | FP/S | ||
| 200/10 μg | 250/50 μg | 400/10 μg | 500/50 μg | Total | |
| MedDRA Classification, n (%) | n = 141) | n = 68) | n = 130) | n = 65) | n= 404) |
| Infections/ infestations | 86(61.0) | 46 (67.6) | 76(58.5) | 34 (52.3) | 242 (59.9) |
| Nasopharyngitis | 29 (20.6) | 13(19.1) | 21 (16.2) | 8(12.3) | 71(17.6) |
| Bronchitis | 17(12.1) | 14(20.6) | 20(15.4) | 7(10.8) | 58(14.4) |
| Influenza | 14 (9.9) | 9(13.2) | 13(10.0) | 11(16.9) | 47(11.6) |
| Pharyngitis | 15(10.6) | 9(13.2) | 11(8.5) | 9(13.2)11(8.5) | 44(10.9) |
| Rhinitis | 7 (5.0) | 8(11.8) | 7(5.4) | 1(1.5) | 23 (5.7) |
| URTI | 5(1.5) | 5(7.4) | 5(3.8) | 1(1.5) | 16(4.0) |
| Sinusitis | 7(5.0) | 2 (2.9) | 4(3.1) | 1(1.5) | 14(3.5) |
| Nervous system disorders | 47(33.3) | 20 (29.4) | 36 (27.7) | 13 (20.0) | 116(28.7) |
| Headache | 33 (23.3) | 17(25.0) | 31(23.8) | 13 (20.0) | 94(23.3) |
| Gastrointestinal disorders | 35(24.8) | 22(32.4) | 30(23.1) | 18(27.7) | 105(26.0) |
| Abdominal pain | 4(2.8) | 3 (4.5) | 6 (4.6) | 5(7.7) | 18(4.5) |
| Abdominal pain upper | 3(2.1) | 3 (4.4) | 7(5.4) | 3 (4.6) | 16(4.0) |
| Aphthous stomatitis | 3(2.1) | 4 (5.9) | 3 (2.3) | 0 | 10(2.5) |
| Respiratory, thoracic, mediastinal disorders | 42(29.8) | 19(27.9) | 28(21.5) | 11(16.9) | 100(24.8) |
| Rhinitis allergic | 11(7.8) | 6(8.8) | 9 (6.9) | 5(7.7) | 31(7.7) |
| Pharyngolaryngeal pain | 11(7.8) | 2(2.9) | 7(5.4) | 1(1.5) | 21 (5.2) |
| Dysphonia | 7 (5.0) | 5(7.4) | 5(3.8) | 2(3.1) | 19(4.7) |
| Cough | 8(5.7) | 4(5.9) | 2(1.5) | 2(3.1) | 16(4.0) |
| Musculoskeletal and connective tissue disorders | 21(14.9) | 13(19.1) | 20(15.4) | 11(16.9) | 65(16.1) |
| Back pain | 10(7.1) | 7(10.3) | 6(4.6) | 3 (4.6) | 26 (6.4) |
| Arthralgia | 7(5.0) | 3 (4.2) | 4(3.1) | 3 (4.6) | 17 (4.2) |
| Muscle spasms | 2(1.4) | 2(2.9) | 3 (2.3) | 4 (6.2) | 11(2.7) |
| General disorders and administrative site conditions | 19(13.5) | 9(13.2) | 13(10.0) | 5(7.7) | 46(11.4) |
| Pyrexia | 8(4.7) | 4(5.9) | 6(4.6) | 1(1.5) | 19(4.7) |
BID, twice daily; FP/S, fluticasone propionate/salmeterol; MDI, metered-dose inhaler; MedDRA, Medical Dictionary for Regulatory Activities; MF/F, mometasone furoate/formoterol; URTI, upper respiratory tract infection.