TABLE 2.
Patients with ≥1 moderate, ≥1 severe and ≥1 moderate or severe on-treatment exacerbations during the study period by exacerbation history in the year prior to screening
| Exacerbation history subgroups | On-treatment COPD exacerbations | |||||
| Moderate only | Severe only | Moderate or severe | ||||
| FF/UMEC/VI | ||||||
| Single moderate | 486 (41) | 708.1 [750] | 112 (9) | 121.8 [129] | 545 (45) | 829.9 [879] |
| Frequent moderate | 797 (43) | 805.4 [1368] | 117 (6) | 77.7 [132] | 859 (46) | 883.1 [1500] |
| Severe | 436 (40) | 783.7 [750] | 218 (20) | 312.4 [299] | 555 (51) | 1096.1 [1049] |
| FF/VI | ||||||
| Single moderate | 542 (44) | 857.8 [870] | 108 (9) | 135.1 [137] | 605 (49) | 992.9 [1007] |
| Frequent moderate | 799 (44) | 882.2 [1384] | 120 (7) | 89.2 [140] | 847 (46) | 971.4 [1524] |
| Severe | 454 (42) | 914.4 [800] | 233 (22) | 348.6 [305] | 587 (55) | 1263.0 [1105] |
| UMEC/VI | ||||||
| Single moderate | 252 (41) | 849.1 [429] | 55 (9) | 120.7 [61] | 281 (46) | 969.9 [490] |
| Frequent moderate | 430 (46) | 1002.1 [790] | 96 (10) | 145.9 [115] | 478 (51) | 1147.9 [905] |
| Severe | 205 (40) | 958.8 [388] | 121 (23) | 410.2 [166] | 277 (54) | 1369.0 [554] |
Data are presented as n (%) or rate [number of events]. Rate is reported per 1000 subject-years, calculated as the number of events×1000, divided by the total duration at risk. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.