Table 2 Summary of safety data (pooled safety population)
GFF MDI 18/9.6 μg (n = 1588) | GP MDI 18 μg (n = 1364) | FF MDI 9.6 μg (n = 1370) | Placebo MDI (n = 678) | All patients (n = 5000) | |
|---|---|---|---|---|---|
TEAEs, n (%) [number of events] | |||||
≥ 1 TEAE | 923 (58.1) [2317] | 750 (55.0) [1946] | 762 (55.6) [1866] | 386 (56.9) [921] | 2821 (56.4) [7050] |
Mild | 396 (24.9) | 317 (23.2) | 348 (25.4) | 174 (25.7) | 1235 (24.7) |
Moderate | 404 (25.4) | 326 (23.9) | 308 (22.5) | 162 (23.9) | 1200 (24.0) |
Severe | 123 (7.7) | 107 (7.8) | 106 (7.7) | 50 (7.4) | 386 (7.7) |
Drug-relateda TEAEs | 172 (10.8) [276] | 150 (11.0) [256] | 144 (10.5) [228] | 69 (10.2) [115] | 535 (10.7) [875] |
Serious TEAEs | 133 (8.4) [171] | 107 (7.8) [155] | 106 (7.7) [129] | 50 (7.4) [65] | 396 (7.9) [520] |
Drug-relateda serious TEAEs | 10 (0.6) [11] | 15 (1.1) [21] | 8 (0.6) [9] | 3 (0.4) [3] | 36 (0.7) [44] |
TEAEs leading to early discontinuation | 91 (5.7) [125] | 80 (5.9) [133] | 71 (5.2) [120] | 43 (6.3) [56] | 285 (5.7) [434] |
Deaths (all causes) | |||||
Treatment period | 5 (0.3) | 1 (0.1) | 2 (0.1) | 2 (0.3) | 10 (0.2) |
Treatment period + 14 days | 6 (0.4) | 2 (0.1) | 2 (0.1) | 2 (0.3) | 12 (0.2) |
TEAEs occurring in ≥2% of patients in any treatment arm, preferred term, n (%) | |||||
Upper respiratory tract infection | 70 (4.4) | 67 (4.9) | 59 (4.3) | 42 (6.2) | 238 (4.8) |
Viral upper respiratory tract infection | 75 (4.7) | 61 (4.5) | 71 (5.2) | 26 (3.8) | 233 (4.7) |
Cough | 54 (3.4) | 37 (2.7) | 32 (2.3) | 14 (2.1) | 137 (2.7) |
COPDb | 40 (2.5) | 42 (3.1) | 30 (2.2) | 20 (2.9) | 132 (2.6) |
Dyspnea | 35 (2.2) | 32 (2.3) | 35 (2.6) | 26 (3.8) | 128 (2.6) |
Nasopharyngitis | 45 (2.8) | 25 (1.8) | 29 (2.1) | 19 (2.8) | 118 (2.4) |
Sinusitis | 28 (1.8) | 27 (2.0) | 33 (2.4) | 16 (2.4) | 104 (2.1) |
Headache | 30 (1.9) | 31 (2.3) | 35 (2.6) | 7 (1.0) | 103 (2.1) |
Back pain | 36 (2.3) | 29 (2.1) | 25 (1.8) | 11 (1.6) | 101 (2.0) |
Bronchitis | 24 (1.5) | 35 (2.6) | 18 (1.3) | 17 (2.5) | 94 (1.9) |
Hypertension | 28 (1.8) | 20 (1.5) | 21 (1.5) | 24 (3.5) | 93 (1.9) |
Pneumonia | 28 (1.8) | 24 (1.8) | 18 (1.3) | 17 (2.5) | 87 (1.7) |
Urinary tract infection | 33 (2.1) | 21 (1.5) | 14 (1.0) | 12 (1.8) | 80 (1.6) |