Table 2.
Rates of radiological investigation and pneumonia in patients treated with FF/UMEC/VI, FF/VI and UMEC/VI in Asia and the non-Asia regions
| FF/UMEC/VI | FF/VI | UMEC/VI | ||||
|---|---|---|---|---|---|---|
| Asia N = 654 |
Non-Asia N = 3497 |
Asia N = 660 |
Non-Asia N = 3474 |
Asia N = 330 |
Non-Asia N = 1740 |
|
| Number of patients with investigator-reported pneumonia, n (%) | 88 (13) | 224 (6) | 92 (14) | 190 (5) | 19 (6) | 76 (4) |
| Number of patients with investigator-reported pneumonia supported by infiltrate on CXR/CT, n (%) | 47 (7) | 107 (3) | 59 (9) | 88 (3) | 11 (3) | 29 (2) |
| Number of investigator-reported pneumonia events, n [ratea] | 99 [163.2] | 247 [79.5] | 109 [187.7] | 210 [73.0] | 20 [69.4] | 81 [57.4] |
| Number of investigator-reported pneumonia events for which CXR/CT taken, n/N (%) | 91/99 (92) | 193/247 (78) | 102/109 (94) | 161/210 (77) | 16/20 (80) | 57/81 (70) |
| Proportion of CXR/CT showing an infiltrate, n/N (%) | 51/91 (56) | 115/193 (60) | 65/102 (64) | 91/161 (57) | 11/16 (69) | 29/57 (51) |
| Number of investigator-reported pneumonia events with infiltrate on CXR/CT, n/N (%) | 51/99 (52) | 115/247 (47) | 65/109 (60) | 91/210 (43) | 11/20 (55) | 29/81 (36) |
| Number of patients with pneumonia AESIb, n (%) | 91 (14) | 226 (6) | 98 (15) | 194 (6) | 21 (6) | 76 (4) |
| Number of pneumonia AESIb, n [ratea] | 105 [173.1] | 251 [80.8] | 119 [204.9] | 215 [74.7] | 23 [79.8] | 81 [57.4] |
| Number of patients with serious pneumonia AESI, n (%) | 58 (9) | 142 (4) | 66 (10) | 105 (3) | 10 (3) | 47 (3) |
| Number of serious pneumonia AESI, n [ratea] | 65 [107.1] | 153 [49.2] | 74 [127.4] | 113 [39.3] | 11 [38.2] | 49 [34.7] |
| Number of patients with fatal serious pneumonia AESI, n (%) | 3 (< 1) | 9 (< 1) | 3 (< 1) | 2 (< 1) | 1 (< 1) | 4 (< 1) |
| Number of fatal serious pneumonia AESI, n [ratea] | 4 [6.6] | 9 [2.9] | 4 [6.9] | 2 [0.7] | 1 [3.5] | 4 [2.8] |
| Number of patients with adjudicated SAR pneumonia/RTIc, n (%) | 48 (7) | 128 (4) | 58 (9) | 122 (4) | 26 (8) | 50 (3) |
| Number of adjudicated SAR pneumonia/RTIc, n [ratea] | 60 [98.9] | 147 [47.3] | 64 [110.2] | 135 [46.9] | 32 [111.1] | 55 [39.0] |
| Pneumonia AESI rate according to CMH statusd, n [ratea] | ||||||
| CMH + | 71 [196.7] | 158 [82.4] | 64 [187.0] | 142 [78.3] | 11 [67.3] | 53 [60.9] |
| CMH− | 34 [141.9] | 91 [78.4] | 54 [232.2] | 71 [68.6] | 12 [97.1] | 28 [53.4] |
AESI adverse event of special interest, CMH chronic mucus hypersecretion, CT computerized tomography, CXR chest X-ray, FF fluticasone furoate, RTI respiratory tract infection, SAR serious adverse report, UMEC umeclidinium, VI vilanterol
aRate per 1000 subject-years
bPneumonia AESI included the following terms: pneumonia bacterial, pulmonary tuberculosis, lung infection, pneumonitis, tuberculosis, Aspergillus infection, empyema, pneumonia fungal, pneumonia Haemophilus, pneumonia Klebsiella, pneumonia necrotizing
cWith and without COPD exacerbation, adjudicated as the primary event in the serious adverse report; adjudicated on-treatment adverse events are those that occur between study treatment start date and 1 day after study treatment stop date, inclusive
dBased on SGRQ responses