Summary of adverse events in the VivaTinA-asthma, PensieTinA-asthma and RubaTinA-asthma trials
| n (%) | Tiotropium Respimat® 5 µg QD | Tiotropium Respimat® 2.5 µg QD | Placebo Respimat® QD | |
|---|---|---|---|---|
| VivaTinA-asthma®, 6–11 years | n = 130 | n = 136 | n = 134 | |
| Overall AEs | ||||
| Patients with any AE | 56 (43.1) | 59 (43.4) | 66 (49.3) | |
| Patients with investigator-defined drug-related AEs | 1 (0.8) | 0 | 2 (1.5) | |
| Patients with AEs leading to discontinuation | 2 (1.5) | 0 | 2 (1.5) | |
| Patients with serious AEs | 4 (3.1) | 2 (1.5) | 2 (1.5) | |
| AEs in >5% pts in any treatment group, by preferred term | ||||
| Asthmaa | 24 (18.5) | 20 (14.7) | 30 (22.4) | |
| Decreased peak expiratory flow rate | 15 (11.5) | 15 (11.0) | 20 (14.9) | |
| Nasopharyngitis | 6 (4.6) | 6 (4.4) | 11 (8.2) | |
|
PensieTinA-asthma® and RubaTinA-asthma®
: 12–17 years | n = 264 | n = 252 | n = 273 | |
| Overall AEs | ||||
| Patients with any AE | 127 (48.1) | 121 (48.0) | 130 (47.6) | |
| Patients with investigator-defined drug-related AEs | 4 (1.5) | 1 (0.4) | 2 (0.7) | |
| Patients with AEs leading to discontinuation | 0 | 0 | 3 (1.1) | |
| Patients with serious AEs | 5 (1.9) | 3 (1.2) | 2 (0.7) | |
| AEs in >5% pts in any treatment group, by preferred term | ||||
| Asthmaa | 38 (14.4) | 41 (16.3) | 46 (16.8) | |
| Decreased peak expiratory flow rate | 11 (4.2) | 18 (7.1) | 21 (7.7) | |
| Nasopharyngitis | 25 (9.5) | 19 (7.5) | 21 (7.7) | |
| Viral respiratory tract infection | 11 (4.2) | 11 (4.4) | 14 (5.1) | |
Treated set. Percentages calculated using total number of patients per treatment as denominator. AE preferred terms defined by Medical Dictionary for Regulatory Activities version 16.1 or 18.0. Tiotropium Respimat® or placebo Respimat® administered as add-on to background therapy
aRepresents asthma worsening or exacerbation
Please refer to page A272 for declarations of interest in relation to abstract P155.