Table S1.
TEAEs reported in ≥1% of patients with any treatment in safety population (integrated analysis)
| BDP/FF/GB 400/24/50 µg N=1,764
|
BDP/FF 400/24 µg N=680
|
Tiotropium 18 µg N=1,076
|
BDP/FF 400/24 µg + tiotropium 18 µg N=537
|
|||||
|---|---|---|---|---|---|---|---|---|
| Number of events | Number of patients (%) | Number of events | Number of patients (%) | Number of events | Number of patients (%) | Number of events | Number of patients (%) | |
| At least one TEAE | 2,349 | 962 (54.5) | 928 | 379 (55.7) | 1,514 | 622 (57.8) | 740 | 309 (57.5) |
| COPD | 800 | 565 (32.0) | 360 | 240 (35.3) | 588 | 383 (35.6) | 258 | 167 (31.1) |
| Nasopharyngitis | 114 | 96 (5.4) | 45 | 38 (5.6) | 85 | 66 (6.1) | 22 | 20 (3.7) |
| Headache | 69 | 55 (3.1) | 17 | 16 (2.4) | 48 | 41 (3.8) | 20 | 18 (3.4) |
| Pneumonia | 55 | 51 (2.9) | 18 | 18 (2.6) | 20 | 19 (1.8) | 13 | 12 (2.2) |
| Pneumonia | 46 | 43 (2.4) | 16 | 16 (2.4) | 18 | 17 (1.6) | 13 | 12 (2.2) |
| Bronchopneumonia | 4 | 4 (0.2) | 2 | 2 (0.3) | 1 | 1 (0.1) | 0 | 0 (0.0) |
| Lobar pneumonia | 4 | 4 (0.2) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| Interstitial lung disease | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (0.1) | 0 | 0 (0.0) |
| Pneumonia aspiration | 1 | 1 (0.1) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| Dyspnea | 38 | 35 (2.0) | 15 | 13 (1.9) | 52 | 37 (3.4) | 9 | 8 (1.5) |
| Hypertension | 43 | 40 (2.3) | 18 | 16 (2.4) | 21 | 20 (1.9) | 10 | 10 (1.9) |
| Respiratory tract infection viral | 33 | 31 (1.8) | 11 | 10 (1.5) | 15 | 15 (1.4) | 14 | 13 (2.4) |
| Cough | 32 | 24 (1.4) | 7 | 7 (1.0) | 26 | 23 (2.1) | 9 | 9 (1.7) |
| Atrial fibrillation | 26 | 25 (1.4) | 9 | 9 (1.3) | 13 | 13 (1.2) | 5 | 4 (0.7) |
| Influenza | 26 | 24 (1.4) | 5 | 5 (0.7) | 11 | 10 (0.9) | 4 | 4 (0.7) |
| Dry mouth | 15 | 14 (0.8) | 4 | 4 (0.6) | 13 | 13 (1.2) | 10 | 10 (1.9) |
| Back pain | 25 | 23 (1.3) | 8 | 7 (1.0) | 6 | 6 (0.6) | 2 | 2 (0.4) |
| Upper respiratory tract infection | 11 | 9 (0.5) | 12 | 12 (1.8) | 11 | 11 (1.0) | 4 | 4 (0.7) |
| Cardiac failure | 14 | 13 (0.7) | 5 | 5 (0.7) | 9 | 7 (0.7) | 7 | 6 (1.1) |
| Anemia | 12 | 12 (0.7) | 7 | 7 (1.0) | 7 | 7 (0.7) | 3 | 3 (0.6) |
| Viral upper tract infection | 16 | 14 (0.8) | 2 | 2 (0.3) | 6 | 6 (0.6) | 7 | 6 (1.1) |
| Oral candidiasis | 21 | 18 (1.0) | 2 | 2 (0.3) | 3 | 3 (0.3) | 5 | 3 (0.6) |
| Pyrexia | 4 | 3 (0.2) | 0 | 0 (0.0) | 4 | 4 (0.4) | 9 | 7 (1.3) |
| Spinal pain | 2 | 2 (0.1) | 1 | 1 (0.1) | 1 | 1 (0.1) | 8 | 6 (1.1) |
Abbreviations: BDP, beclomethasone dipropionate; FF, formoterol fumarate; GB, glycopyrronium bromide; TEAE, treatment-emerging adverse event.