Adverse events by treatment group in the intention-to-treat population
| Placebo | Theophylline plus placebo | Theophylline plus prednisone | Total | |||||
| Events | Patients | Events | Patients | Events | Patients | Events | Patients | |
| Patients | 554 | 568 | 548 | 1670 | ||||
| Total adverse events | 553 | 267 (48.2) | 529 | 281 (49.5) | 532 | 264 (48.2) | 1614 | 812 (48.6) |
| AECOPD | 441 | 233 (42.1) | 392 | 235 (41.4) | 421 | 231 (42.2) | 1254 | 699 (41.9) |
| URTI | 37 | 28 (5.1) | 54 | 41 (7.2) | 34 | 29 (5.3) | 125 | 98 (5.9) |
| Weight gain | 1 | 1 (0.2) | 1 | 1 (0.2) | 3 | 3 (0.5) | 5 | 5 (0.3) |
| Pneumonia | 3 | 3 (0.5) | 0 | 0 (0.0) | 3 | 2 (0.4) | 6 | 5 (0.3) |
| Fractures | 6 | 6 (1.1) | 2 | 2 (0.4) | 5 | 5 (0.9) | 13 | 13 (0.8) |
| Noninfectious GI upset | 13 | 12 (2.2) | 21 | 18 (3.2) | 13 | 11 (2.0) | 47 | 41 (2.5) |
Data are presented as n or n (%). AECOPD: acute exacerbations of chronic obstructive pulmonary disease; URTI: upper respiratory tract infection; GI: gastrointestinal.