Table 2.
Adverse events, serious adverse events, and deaths (safety set)
| Medium-dose MF/IND/GLY (n = 375) exp = 345.4 years |
High-dose MF/IND/GLY (n = 387) exp = 366.3 |
High-dose MF/IND (n = 393) exp = 367.7 years |
High-dose FLU/SAL (n = 375) exp = 349.0 years |
|
|---|---|---|---|---|
| Patients with ≥ 1 AE | 283 (176.8) | 286 (170.7) | 288 (169.7) | 300 (203.8) |
| Asthma | 143 (54.2) | 145 (52.2) | 160 (59.3) | 183 (76.2) |
| Nasopharyngitis | 44 (13.8) | 41 (12.0) | 49 (14.4) | 55 (17.2) |
| Upper respiratory tract infection | 32 (9.8) | 24 (6.8) | 37 (10.7) | 33 (10.0) |
| Bronchitis | 25 (7.5) | 30 (8.5) | 23 (6.5) | 31 (9.3) |
| Viral upper respiratory tract infection | 22 (6.6) | 10 (2.8) | 28 (7.9) | 32 (9.7) |
| Cough | 11 (3.2) | 18 (5.0) | 5 (1.4) | 7 (2.0) |
| Hypertension | 12 (3.5) | 11 (3.1) | 12 (3.3) | 16 (4.7) |
| Influenza | 14 (4.1) | 11 (3.1) | 10 (2.8) | 11 (3.2) |
| Pharyngitis | 14 (4.1) | 13 (3.6) | 12 (3.3) | 15 (4.4) |
| Upper respiratory tract infection bacterial | 12 (3.5) | 12 (3.3) | 14 (3.9) | 16 (4.7) |
| Lower respiratory tract infection | 5 (1.5) | 8 (2.2) | 10 (2.7) | 18 (5.3) |
| Number of patients with at least 1 AE suspected by the investigator to be study drug related | 28 (8.5) | 32 (9.3) | 24 (6.8) | 29 (8.7) |
| Number of patients with at least 1 AE leading to permanent discontinuation of study drugs | 18 (5.2) | 8 (2.2) | 14 (3.8) | 15 (4.3) |
| Patients with ≥ 1 SAE | 32 (9.6) | 30 (8.5) | 37 (10.4) | 24 (7.1) |
| Asthma | 9 (2.6) | 5 (1.4) | 7 (1.9) | 7 (2.0) |
| Pneumonia | 2 (0.6) | 3 (0.8) | 0 | 2 (0.6) |
| Lower respiratory tract infection | 0 | 1 (0.3) | 3 (0.8) | 2 (0.6) |
| Hypertension | 2 (0.6) | 0 | 0 | 0 |
| Cholelithiasis | 0 | 3 (0.8) | 0 | 1 (0.3) |
| Urinary tract infection | 0 | 2 (0.5) | 0 | 1 (0.3) |
| Number of patients with at least 1 SAE suspected by the investigator to be study drug-related | 1 (0.3) | 0 | 4 (1.1) | 1 (0.3) |
| Death | 1 (0.3) | 1 (0.3) | 3 (0.8) | 0 |
| Cancer | 0 | 0 | 1 (0.3) | 0 |
| Cardiovascular | 1 (0.3) | 1 (0.3) | 1 (0.3) | 0 |
| Accidental | 0 | 0 | 1 (0.3) | 0 |
Data are presented as n (IR). IR is reported per 100 patient-years (100 × number of patients with at least one event/time at risk for given adverse event in patient-years). Patients received medium-dose MF/IND/GLY (80/150/50 μg) o.d., or high-dose MF/IND/GLY (160/150/50 μg) o.d., or medium-dose MF/IND (160/150 μg) o.d., or high-dose MF/IND (320/150 μg) o.d., or high-dose FLU/SAL (500/50 μg) b.i.d.
AE adverse event, exp exposure in total number of patient-years, FLU/SAL fluticasone/salmeterol, IR incidence rate, MF/IND mometasone/indacaterol, MF/IND/GLY mometasone/indacaterol/glycopyrronium, SAE serious AE