Table 3.
Adverse events
| Subgroup | All patients | COPD history | CB ± emphysema and ICS treatment | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Emphysema | CB ± emphysema | With ICS | Without ICS | |||||||
| Treatment (n) | Rof (1327) | Pbo (1359) | Rof (352) | Pbo (413) | Rof (817) | Pbo (847) | Rof (492) | Pbo (493) | Rof (325) | Pbo (354) |
| Adverse events, n (% of patients) | ||||||||||
| All adverse events | 1081 (81.5) | 1089 (80.1) | 309 (87.8) | 344 (83.3) | 642 (78.6) | 673 (79.5) | 402 (81.7) | 399 (80.9) | 240 (73.8) | 274 (77.4) |
| All serious adverse events | 263 (19.8) | 264 (19.4) | 73 (20.7) | 81 (19.6) | 154 (18.8) | 152 (17.9) | 112 (22.8) | 109 (22.1) | 42 (12.9) | 43 (12.1) |
| Adverse events related to study medication | 285 (21.5) | 113 (8.3) | 91 (25.9) | 39 (9.4) | 134 (16.4) | 67 (7.9) | 77 (15.7) | 35 (7.1) | 57 (17.5) | 32 (9.0) |
| Adverse events leading to study discontinuation | 235 (17.7) | 136 (10.0) | 52 (14.8) | 40 (9.7) | 94 (11.5) | 56 (6.6) | 65 (13.2) | 40 (8.1) | 29 (8.9) | 16 (4.5) |
| Most common adverse events (≥ 5% of patients in any treatment group), % | ||||||||||
| COPD exacerbation | 42.9 | 48.0 | 45.5 | 47.7 | 43.0 | 48.5 | 49.8 | 54.4 | 32.6 | 40.4 |
| Diarrhea | 12.1 | 2.9 | 18.5 | 3.4 | 7.1 | 3.1 | 8.3 | 3.2 | 5.2 | 2.8 |
| Nausea | 6.0 | 1.5 | 8.0 | 1.9 | 4.4 | 1.3 | 4.7 | 1.0 | 4.0 | 1.7 |
| Weight loss | 7.5 | 2.8 | 11.9 | 4.1 | 6.1 | 2.5 | 5.3 | 1.6 | 7.4 | 3.7 |
| Nasopharyngitis | 6.8 | 7.4 | 7.7 | 8.2 | 7.5 | 7.7 | 6.5 | 7.3 | 8.9 | 8.2 |
| Pneumonia | 2.8 | 4.0 | 1.7 | 2.9 | 3.5 | 4.1 | 4.3 | 5.7 | 2.5 | 2.0 |
| Upper respiratory tract infection | 5.4 | 6.3 | 7.4 | 9.2 | 5.4 | 5.5 | 4.5 | 5.1 | 6.8 | 6.2 |
| Headache | 6.9 | 3.0 | 8.5 | 5.3 | 5.6 | 2.1 | 6.1 | 2.2 | 4.9 | 2.0 |
| Influenza | 4.4 | 4.0 | 5.4 | 5.3 | 4.4 | 3.7 | 4.5 | 2.2 | 4.3 | 5.6 |
Rof = roflumilast; pbo = placebo