Table 3 Summary of adverse events
NMT | MT | |||||||
|---|---|---|---|---|---|---|---|---|
Treatment | GFF (n = 638) | FF (n = 548) | GP (n = 516) | Placebo (n = 241) | GFF (n = 947) | FF (n = 812) | GP (n = 846) | Placebo (n = 435) |
TEAEs, n (%) | ||||||||
Patients with ≥1 TEAE | 362 (56.7) | 304 (55.5) | 280 (54.3) | 133 (55.2) | 560 (59.1) | 457 (56.3) | 469 (55.4) | 252 (57.9) |
Patients with serious TEAEs | 43 (6.7) | 33 (6.0) | 35 (6.8) | 18 (7.5) | 90 (9.5) | 73 (9.0) | 72 (8.5) | 32 (7.4) |
Deaths (all-cause) during treatment period | 1 (0.2) | 1 (0.2) | 0 (0) | 1 (0.4) | 4 (0.4) | 1 (0.1) | 1 (0.1) | 1 (0.2) |
TRAEs, n (%) | ||||||||
Patients with TEAEs related to study treatment | 75 (11.8) | 58 (10.6) | 51 (9.9) | 19 (7.9) | 97 (10.2) | 86 (10.6) | 99 (11.7) | 50 (11.5) |
Patients with serious TEAEs related to study treatment | 7 (1.1) | 1 (0.2) | 6 (1.2) | 1 (0.4) | 3 (0.3) | 7 (0.9) | 9 (1.1) | 2 (0.5) |
Common TEAEs, n (%) | ||||||||
Upper respiratory tract infection | 28 (4.4) | 20 (3.6) | 26 (5.0) | 13 (5.4) | 42 (4.4) | 39 (4.8) | 41 (4.8) | 29 (6.7) |
Viral upper respiratory tract infection | 31 (4.9) | 28 (5.1) | 20 (3.9) | 10 (4.1) | 44 (4.6) | 43 (5.3) | 41 (4.8) | 16 (3.7) |
Dyspnea | 11 (1.7) | 8 (1.5) | 7 (1.4) | 7 (2.9) | 24 (2.5) | 27 (3.3) | 25 (3.0) | 19 (4.4) |
Nasopharyngitis | 14 (2.2) | 14 (2.6) | 9 (1.7) | 10 (4.1) | 31 (3.3) | 15 (1.8) | 16 (1.9) | 9 (2.1) |
Back pain | 17 (2.7) | 12 (2.2) | 10 (1.9) | 9 (3.7) | 19 (2.0) | 13 (1.6) | 19 (2.2) | 2 (0.5) |
Cough | 23 (3.6) | 11 (2.0) | 14 (2.7) | 6 (2.5) | 31 (3.3) | 21 (2.6) | 23 (2.7) | 8 (1.8) |
COPD | 14 (2.2) | 11 (2.0) | 16 (3.1) | 5 (2.1) | 26 (2.7) | 19 (2.3) | 26 (3.1) | 15 (3.4) |
Bronchitis | 9 (1.4) | 5 (0.9) | 9 (1.7) | 2 (0.8) | 15 (1.6) | 13 (1.6) | 26 (3.1) | 15 (3.4) |
Hypertension | 14 (2.2) | 5 (0.9) | 6 (1.2) | 8 (3.3) | 14 (1.5) | 16 (2.0) | 14 (1.7) | 16 (3.7) |
Headache | 15 (2.4) | 17 (3.1) | 11 (2.1) | 3 (1.2) | 15 (1.6) | 18 (2.2) | 20 (2.4) | 4 (0.9) |