Table 6.
The frequency (n [%]) of patients with ≥3% adverse events in any treatment group and mortality data
| Tiotropium Respimat® SMI 5 μg (n = 670) | Tiotropium Respimat® SMI 10 μg (n = 667) | Placebo (n = 653) | |
|---|---|---|---|
| Patients with any adverse event | 505 (75.4) | 525 (78.7) | 502 (76.9) |
| With serious adverse events | 108 (16.1) | 125 (18.7) | 110 (16.8) |
| Mean exposure to treatment (days) | 304.7 | 297.2 | 265.6 |
| Gastrointestinal disorders | 142 (21.2) | 193 (28.9) | 97 (14.9) |
| General disorders and administration site conditions | 54 (8.1) | 33 (4.9) | 39 (6.0) |
| Infections and infestations | 90 (13.4) | 95 (14.2) | 79 (12.1) |
| Musculoskeletal and connective tissues disorders | 94 (14.0) | 100 (15.0) | 78 (11.9) |
| Nervous system disorders | 75 (11.2) | 65 (9.7) | 66 (10.1) |
| Lower respiratory system disorders | 304 (45.4) | 299 (44.8) | 360 (55.1) |
| Upper respiratory system disorders | 208 (31.0) | 203 (30.4) | 171 (26.2) |
| Vascular disorders | 30 (4.5) | 41 (6.1) | 35 (5.4) |
| All-cause mortality on treatment plus 30-day observation period† | 12 (1.79) | 17 (2.55)* | 5 (0.77) |
| All-cause mortality including discontinued patients‡ | 16 (2.39) | 18 (2.70) | 10 (1.53) |
*
P = 0.0161 vs placebo.
†
All fatal adverse events reported until day 369; this reflects the mean exposure to treatment for study completers plus the 30-day observation period. However, four known fatal events were excluded from this analysis: 2 cases in the placebo group had unknown outcomes and 1 case in each of the active treatment groups as the patients died more than 366 days after their first dose of medication.
‡
This also includes the retrospective study 205.392.
Notes: Classified using Medical Dictionary for Regulatory Activities (MedDRA Version 8) system organ class.
Abbreviations: SMI, Soft Mist™ Inhaler.