Table 2.
Summary of events and characteristics by study
| SUN (n = 989) | SHINE (n = 561) | US3 (n = 807) | RISE (n = 1219) | |||||
|---|---|---|---|---|---|---|---|---|
| BUD/FORM 160/4.5 μg bid (n = 494) | FORM 4.5 μg bid (n = 495) |
BUD/FORM 160/4.5 μg bid (n = 277) | FORM 4.5 μg bid (n = 284) |
BUD/FORM 160/4.5 μg bid (n = 404) | FORM 4.5 μg bid (n = 403) |
BUD/FORM 160/4.5 μg bid (n = 606) | FORM 4.5 μg bid (n = 613) |
|
| Any CID | 343 (69.4) | 360 (72.7) | 173 (62.5) | 196 (69.0) | 280 (69.3) | 305 (75.7) | 468 (77.2) | 517 (84.3) |
| Subtypes of first CID | ||||||||
| Exacerbation alone | 81 (23.6) | 96 (26.7) | 47 (27.2) | 47 (24.0) | 114 (40.7) | 126 (41.3) | 61 (13.0) | 74 (14.3) |
| FEV1 event alone | 120 (35.0) | 112 (31.1) | 62 (35.8) | 59 (30.1) | 90 (32.1) | 86 (28.2) | 172 (36.8) | 174 (33.7) |
| SGRQ alone | 116 (33.8) | 112 (31.1) | 49 (28.3) | 76 (38.8) | 61 (21.8) | 75 (24.6) | 172 (36.8) | 171 (33.1) |
| Exacerbation + FEV1 | 3 (0.9) | 5 (1.4) | 0 (0.0) | 2 (1.0) | 6 (2.1) | 8 (2.6) | 5 (1.1) | 7 (1.4) |
| Exacerbation + SGRQ | 3 (0.9) | 4 (1.1) | 4 (2.3) | 2 (1.0) | 1 (0.4) | 4 (1.3) | 6 (1.3) | 7 (1.4) |
| FEV1 + SGRQ | 20 (5.8) | 30 (8.3) | 10 (5.8) | 10 (5.1) | 7 (2.5) | 5 (1.6) | 51 (10.9) | 79 (15.3) |
| Exacerbation + FEV1 + SGRQ | 0 (0) | 1 (0.3) | 1 (0.6) | 0 (0) | 1 (0.4) | 1 (0.3) | 1 (0.2) | 5 (1.0) |
| Individual components | ||||||||
| Exacerbations | 152 (30.8) | 177 (35.8) | 69 (24.9) | 78 (27.5) | 169 (41.8) | 182 (45.2) | 151 (24.9) | 181 (29.5) |
| FEV1 events | 196 (39.7) | 212 (42.8) | 84 (30.3) | 100 (35.2) | 135 (33.4) | 161 (40.0) | 289 (47.7) | 344 (56.1) |
| SGRQ events | 188 (38.1) | 202 (40.8) | 81 (29.2) | 116 (40.8) | 143 (35.4) | 164 (40.7) | 312 (51.5) | 357 (58.2) |
Event rates in percentage of total number of patients; CID sub-events in percentage of total CID events
The rows with individual components (exacerbations, FEV1 events, SGRQ events) describe events as independent variables, whereas the subtypes of first CID events describe the variable/combination occurring first within a patient. Bid, twice daily; BUD Budesonide, CID Clinically Important Deterioration, FEV1 Forced expiratory volume in 1 s, FORM Formoterol, SGRQ St George’s Respiratory Questionnaire